Identity
- Trade Name
- Injection Pen Needle EUDAMED
- Device Name
- Injection Pen Needle EUDAMED
- Model / Reference
- 0.23×4mm/32G RW EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16971953350362 EUDAMED
- Basic UDI-DI
- 697195335321202FMI3240RZ3 EUDAMED
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Injection Pen Needle by Gangan Medical Technology Jiangsu 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 | 697195335321202FMI3240RZ3 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gangan Medical Technology Jiangsu Co., LTD
- EUDAMED SRN
- CN-MF-000007635
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED a4e3247d-7a1d-4989-9c37-4f2a56f80d40 61 fields · synced Jul 19, 2026