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Disposable Hand Assist Tunnels
EUDAMEDClass IIa (EU MDR)
Ref SQB70/70－35/40Model SQA60/70－60/150
Identity
- Trade Name
- Disposable Hand Assist Tunnels EUDAMED
- Device Name
- Disposable Hand Assist Tunnels EUDAMED
- Model / Reference
- SQA60/70－60/150 EUDAMEDSQB70/70－35/40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946480577189 EUDAMED
- Basic UDI-DI
- 69464805SQA/BWB EUDAMED
- EMDN Code
- K0108 HAND-ASSISTED SURGERY DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Disposable Hand Assist Tunnels 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 | 69464805SQA/BWB | 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 76a2f437-0424-48f2-bd7c-d1fc8249ce5b 61 fields · synced Jun 19, 2026