OEM Epidural Needle Manufacturer & Supplier

An Epidural Needle Manufacturer Built Around Customization

Zhenjiang Gaoguan Medical Appliances Co., Ltd is an epidural needle manufacturer with 20 years of single-use medical device production experience, an ISO 13485 certified quality system, and CE marked products exported to 30+ countries. We produce Tuohy-type epidural needles in steel-core and plastic-core configurations for OEM partners worldwide — as standalone needles and as part of combined epidural/spinal and epidural-only puncture kits.

Epidural needles are unforgiving products. Gauge accuracy, bevel geometry, and depth-marking legibility directly affect clinical performance, and regulators in your market will ask for documented evidence of all three. That is why our OEM program starts with a written specification — not a verbal agreement — covering every dimension listed below.

Customization Dimensions: Build Your Exact Epidural Needle

Dimension	Available Options	Notes for OEM Customers
Medidor	15G, 16G, 17G, 18G	16G and 18G are the most commonly ordered; gauge choice affects flow rate and patient comfort trade-offs (see calibre da agulha epidural)
Core type	Steel core (AN-E15G series) or plastic core (AN-E16G/18G series)	Steel core for rigidity preference; plastic core where metal detection or imaging considerations apply full specification sheet provided per model on request
Bevel	Tuohy-type curved (Husted) tip, custom bevel angle short bevel configurations; custom angles within validated range	Tip geometry affects lateral deflection and tissue penetration feel
Depth markings	Every 1 cm or per your market convention; laser or printed depth markings	Marking durability is a common audit finding — we test legibility through packaging sterilization
Radiopaque options	Radiopaque formulations for fluoroscopic identification	Relevant for pain management and catheter placement workflows (radiopaque epidural needles)
Comprimento	Standard adult lengths;25–70 mm typical; custom lengths on request	Match to your market’s body-habitus and technique norms
Hub & wing design	Existing molds or ODM configuration	Wings affect loss-of-resistance handling
Embalagem	Individual peel pack, multi-pack, kit integration, private label printing	All packaging validated to ISO 11607 EO or gamma sterilization per product validation

Typical Customization Combinations

We won’t name customers, but the structure of a typical OEM engagement looks like this:

Regional anesthesiology brand (Europe): 18G plastic-core Tuohy needle, 1 cm laser markings, private-label peel pack, supplied alongside a matched 25G–27G pencil-point spinal needle for combined procedures.
Pain-management distributor (Middle East): 16G steel-core needle with radiopaque tubing, custom length, integrated into a branded epidural tray with loss-of-resistance syringe.
Kit integrator (Southeast Asia): Epidural needle supplied as a component of our combined epidural and spinal puncture kit, with customer logo on the outer carton and customer-specified IFU.

Your combination will differ — that is the point of OEM. Send us a reference sample or a drawing and we will map it to production reality.

Quality Control Checkpoints for Epidural Needle Production

Stage	Checkpoint	Method
Incoming	Tubing material, diameter and wall thickness per ISO 9626	Dimensional gauging + material certificates
In-process	Tip grinding geometry and burr control	Optical inspection per sampling plan
In-process	Depth marking accuracy and legibility	Gauging + visual standard in-house visual standards aligned with ISO 7864
Assembly	Hub attachment pull force	Pull-force testing per batch
Finished goods	Sharpness/bending strength sample testing	per applicable ISO standards (ISO 7864, ISO 9626); batch-level pull-force and dimensional sampling
Release	Sterility, EO residual (if EO), batch documentation review	Per sterilization validation records

Sharpness is not cosmetic — tip condition drives insertion force and patient comfort. If you want the engineering context, read our guide on anesthesia needle sharpness and patient comfort.

Why Source Epidural Needles from Gaoguan

20 years of needle manufacturing — the grinding and hub-assembly processes are mature, not experimental
Both steel-core and plastic-core platforms, so one supplier covers your full gauge range
Needles available standalone or pre-configured into epidural and combined epidural/spinal kits, saving you a second vendor qualification
Batch documentation structured to support your market’s registration and import requirements

Perguntas frequentes

What gauges of epidural needles can you manufacture for OEM?

We produce Tuohy-type epidural needles from 15G to 18G in both steel-core and plastic-core versions. Custom gauges and lengths can be evaluated against tooling and validation requirements — send your specification for feasibility review.

Can you print our brand on the packaging and the hub?

Yes. Private label packaging (peel pouch printing, carton, IFU) is standard for OEM orders. Hub printing or color coding is available depending on mold configuration (available on request).

Do you supply epidural needles as part of complete kits?

Yes. We manufacture epidural-only and combined epidural/spinal puncture kits, and we can build custom packs around your needle specification with your chosen components.

What documentation do you provide for import and registration?

Each shipment includes certificates of conformity, sterilization records, and batch release documents. For registration purposes, we provide technical documentation inputs within our manufacturing scope ISO 13485 certificate, CE documentation, Free Sale Certificate, technical descriptions, sterilization validation and batch test reports.

What is your MOQ for custom epidural needles?

MOQ depends on gauge, customization depth, and packaging. We operate a flexible MOQ program for first and trial orders — see our Low MOQ OEM page and request the framework from 500 pcs (standard) to 3,000 pcs (custom).

Fabricante e fornecedor OEM de agulhas epidurais