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Disposable Skin Staplers
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref DSSB-35-WModel DSSA-15/25/35-R/W, DSSB-15/25/35-R/W,
Identity
- Trade Name
- Disposable Skin Staplers EUDAMEDFDA UDI
- Generic Name
- Skin stapler/staple, non-bioabsorbable FDA UDI
- Device Name
- Disposable Skin Staplers EUDAMED
- Model / Reference
- DSSA-15/25/35-R/W, DSSB-15/25/35-R/W, EUDAMEDDSSB-35-W EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06946480584163 EUDAMEDFDA UDI
- Basic UDI-DI
- 69464805DSSA/BV2 EUDAMED
- Direct Marketing DI
- 06946480584163 EUDAMED
- FDA Product Code
- QQS FDA UDI
- EMDN Code
- H02010101 SKIN STAPLERS, SINGLE-USE EUDAMED
- GMDN Term
- Skin stapler/staple, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4740 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 Staplers by Sinolinks Medical Innovation, Inc. — Class IIa — 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 | 69464805DSSA/BV2 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 b462e9fd-0143-496b-8e28-90006435ec30 61 fields · synced Jun 18, 2026
- FDA UDI 5322e130-405b-48f5-8708-b4953d871442 32 fields · synced May 30, 2026