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Elite Skin Stapler
EUDAMEDClass IIa (EU MDR)
Ref PS9031Model DSSA-15/25/35-R/W, DSSB-15/25/35-R/W,
Identity
- Trade Name
- Elite Skin Stapler EUDAMED
- Device Name
- Disposable Skin Staplers EUDAMED
- Model / Reference
- DSSA-15/25/35-R/W, DSSB-15/25/35-R/W, EUDAMEDPS9031 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051223037590 EUDAMED
- Basic UDI-DI
- 69464805DSSA/BV2 EUDAMED
- EMDN Code
- H02010101 SKIN STAPLERS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Elite Skin Stapler by Sinolinks Medical Innovation, Inc. — 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 | 69464805DSSA/BV2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sinolinks Medical Innovation, Inc.
- EUDAMED SRN
- CN-MF-000010840
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED f4d1036a-c13b-4a30-a183-5ab9d77557d7 61 fields · synced Jul 23, 2026