Identity
- Device Name
- Skin Staplers and Removers EUDAMED
- Model / Reference
- PFR35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949298921021 EUDAMED
- Basic UDI-DI
- B-06949298921021 EUDAMED
- EMDN Code
- H02010102 SKIN STAPLERS, SINGLE PATIENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMEDEUDAMED
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 IIb — 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-06949298921021 | Class IIb | 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 (2)
- EUDAMED 80978bb1-d112-490f-86d8-8119dba0fd58 61 fields · synced Jun 18, 2026
- EUDAMED fe4810b5-fd7e-4870-acf6-cf769a8bd7de 61 fields · synced Jun 18, 2026