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Disposable Trocars
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AVTB 5-100Model AVTB 5-70
Identity
- Trade Name
- Disposable Trocars EUDAMEDFDA UDI
- Generic Name
- Laparoscopic access cannula, single-use FDA UDI
- Device Name
- Disposable Trocars EUDAMED
- Model / Reference
- AVTB 5-70 EUDAMEDAVTB 5-100 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06946480582060 EUDAMEDFDA UDI
- Basic UDI-DI
- 69464805AVT6C EUDAMED
- 510(k) Number
- K250820 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- K01010101 TROCAR STANDARD, SINGLE-USE EUDAMED
- GMDN Term
- Laparoscopic access cannula, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Disposable Trocars 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 | 69464805AVT6C | 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 af8be9b7-8201-4a18-b626-dc0aac7c28cb 61 fields · synced Oct 6, 2026
- FDA UDI 0d41934a-4405-4efa-8654-6122fa430e57 33 fields · synced May 30, 2026