Identity
- Trade Name
- Sterile Acupuncture Needles EUDAMED
- Device Name
- Sterile Acupuncture Needles EUDAMED
- Model / Reference
- 0.25x13mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16901452710138 EUDAMED
- Basic UDI-DI
- B-16901452710138 EUDAMED
- EMDN Code
- A019002 ACUPUNCTURE NEEDLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterile Acupuncture Needles by Suzhou Medical Appliance Factory — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-16901452710138 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Suzhou Medical Appliance Factory
- EUDAMED SRN
- CN-MF-000015855
- Authorised Representative
- Metrax GmbH DE-AR-000005481
Sources (1)
- EUDAMED 797bb317-16f2-4efa-b6ce-33f70a2ecde3 61 fields · synced Jun 19, 2026