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Disposable Skin Staple Removers
EUDAMEDFDA UDIClass I (EU MDR)
Ref SRWModel SRR, SRW
Identity
- Trade Name
- Disposable Skin Staple Removers EUDAMEDFDA UDI
- Generic Name
- Skin staple remover, single-use FDA UDI
- Device Name
- Disposable Skin Staple Removers EUDAMED
- Model / Reference
- SRR, SRW EUDAMEDSRW EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06946480584224 EUDAMEDFDA UDI
- Basic UDI-DI
- 69464805SRR/W2L EUDAMED
- Direct Marketing DI
- 06946480584224 EUDAMED
- FDA Product Code
- KDC FDA UDI
- EMDN Code
- H02010106 METAL SURGICAL STAPLE REMOVERS, SINGLE-USE EUDAMED
- GMDN Term
- Skin staple remover, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Disposable Skin Staple Removers by Sinolinks Medical Innovation, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69464805SRR/W2L | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (2)
- EUDAMED 0079a342-f12e-40d1-962f-289785585d21 61 fields · synced Jul 17, 2026
- FDA UDI 321b9cca-d170-46ed-88c9-b13abc48467d 32 fields · synced May 30, 2026