Identity
- Trade Name
- Applier EUDAMEDAppliers FDA UDI
- Generic Name
- Endoscopic surgical ligation clip applier, reusable FDA UDI
- Device Name
- Applier EUDAMED
- Model / Reference
- CAB\CAC\CRE EUDAMEDCAB 5-S EUDAMEDCA B 5-S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06946480576649 EUDAMEDFDA UDI
- Basic UDI-DI
- 69464805CAC3M EUDAMED
- FDA Product Code
- GDO FDA UDI
- EMDN Code
- H020303 CLIP APPLIERS EUDAMED
- GMDN Term
- Endoscopic surgical ligation clip applier, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Applier 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 | 69464805CAC3M | 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 cc3fbec5-3227-44b6-bb50-273e20be3d87 61 fields · synced Oct 6, 2026
- FDA UDI 55fe9281-651e-422a-8f8d-91d7cd9f445a 32 fields · synced May 29, 2026