Identity
- Trade Name
- Decompression Needle EUDAMED
- Device Name
- Decompression Needle EUDAMED
- Model / Reference
- AZ-DN-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973105232307 EUDAMED
- Basic UDI-DI
- 697310523Needle028G EUDAMED
- EMDN Code
- A019009 DRAINAGE NEEDLES 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Decompression Needle by Anping Guardian Medical Equipment 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 | 697310523Needle028G | Class IIa | Active |
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Manufacturer
- Manufacturer
- Anping Guardian Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000015025
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED b8d69cff-e04c-464d-a3ed-50ba9fdaf73e 61 fields · synced Jun 19, 2026