Identity
- Device Name
- Skin Staplers and Removers EUDAMED
- Model / Reference
- PFW55 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949298920048 EUDAMED
- Basic UDI-DI
- B-06949298920048 EUDAMED
- EMDN Code
- H02010102 SKIN STAPLERS, SINGLE PATIENT 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
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
Skin Staplers and Removers by Jiangsu Brightness Medical Devices Co., Ltd. — 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-06949298920048 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangsu Brightness Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000019184
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (1)
- EUDAMED fa839b7b-b113-4e14-b80b-e7aa89c54345 61 fields · synced Jun 18, 2026