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Disposable skin staplers
EUDAMEDClass IIa (EU MDR)
Ref OBS-MW,OBS-MH,OBS-MR,OBS-FW,OBS-FH,OBS-FR
Identity
- Trade Name
- Disposable skin staplers EUDAMED
- Device Name
- Disposable skin staplers EUDAMED
- Model / Reference
- OBS-MW,OBS-MH,OBS-MR,OBS-FW,OBS-FH,OBS-FR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939411505283 EUDAMED
- Basic UDI-DI
- 69394115OBSDSVJ EUDAMED
- Direct Marketing DI
- 06939411505283 EUDAMED
- EMDN Code
- H02010101 SKIN STAPLERS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland 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
Disposable skin staplers by Baisheng Medical 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 | 69394115OBSDSVJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Baisheng Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000024558
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED 3e012271-9542-4103-aa35-c89dfc4bb3a0 61 fields · synced Jun 19, 2026
- EUDAMED 3e012271-9542-4103-aa35-c89dfc4bb3a0-1 61 fields · synced Jun 10, 2026