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Disposable Hypodermic Needle
EUDAMEDClass IIa (EU MDR)
Ref DN16Model 27G 26G 25G 24G 23G 22G 21G 20G 18G 16G
Identity
- Trade Name
- Disposable Hypodermic Needle EUDAMED
- Device Name
- Disposable Hypodermic Needle EUDAMED
- Model / Reference
- 27G 26G 25G 24G 23G 22G 21G 20G 18G 16G EUDAMEDDN16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971603584058 EUDAMED
- Basic UDI-DI
- 697160358WDHNNT EUDAMED
- EMDN Code
- A0101010102 HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Hypodermic Needle by Shantou Wealy Medical Instrument Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697160358WDHNNT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shantou Wealy Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000020619
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED a2250125-6095-43b7-8d98-4eff474b2b6e 61 fields · synced Jun 18, 2026