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Guang An Men
EUDAMEDClass IIa (EU MDR)
Ref PL3-025×40Model 0.16×15mm,0.16×30mm,0.18×15mm,0.18×30mm,0.20×15mm,0.20×30mm,0.20×40mm,0.22×25mm,0.25×25mm,0.25×30mm,0.25×40mm,0.30×40mm,0.30×25mm,0.30×30mm,0.30×50mm,0.40×25mm,0.40×40mm,0.40×60mm,0.20×13mm,0.20×25mm,0.25×40mm,0.30×40mm,0.30×25mmRef PL3-030×25Ref PL3-020×25Ref PL3-020×13
Identity
- Trade Name
- Guang An Men EUDAMED
- Device Name
- Sterile Acupuncture Needles for Single Use EUDAMED
- Model / Reference
- 0.16×15mm,0.16×30mm,0.18×15mm,0.18×30mm,0.20×15mm,0.20×30mm,0.20×40mm,0.22×25mm,0.25×25mm,0.25×30mm,0.25×40mm,0.30×40mm,0.30×25mm,0.30×30mm,0.30×50mm,0.40×25mm,0.40×40mm,0.40×60mm,0.20×13mm,0.20×25mm,0.25×40mm,0.30×40mm,0.30×25mm EUDAMEDPL3-025×40 EUDAMEDPL3-030×25 EUDAMEDPL3-020×25 EUDAMEDPL3-020×13 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977427145406 EUDAMED06977427145420 EUDAMED06977427145390 EUDAMED06977427145383 EUDAMED
- Basic UDI-DI
- 697168527ZJZ004WW EUDAMED
- EMDN Code
- A019002 ACUPUNCTURE 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
Guang An Men by Changchun AiK Medical Devices 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 | 697168527ZJZ004WW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Changchun AiK Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000026736
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (4)
- EUDAMED fa7845a6-b8dd-4234-b505-f59ef548a9db 61 fields · synced Jul 23, 2026
- EUDAMED 7e4d292d-de5c-48c0-8bbb-bc53d158423c 61 fields · synced May 17, 2026
- EUDAMED c2e03950-9543-4b24-950a-8bd96441ffb9 61 fields · synced May 17, 2026
- EUDAMED 43f5aa85-26bf-4c2d-9148-35f62ef1d065 61 fields · synced May 18, 2026