← Back to catalogue
Disposable Hand Assist Tunnels
EUDAMEDClass IIa (EU MDR)
Ref SQB70/60－35/50Model SQA60/70－60/150 Ref SQB50/40－25/25Ref SQA180/190－180/250Ref SQB50/40－15/20Ref SQA320/330－320/250Ref SQB60/50－25/25Ref SQA80/90－80/150Ref SQB60/50－25/50Ref SQA60/70－60/150Ref SQA270/280－270/250
Identity
- Trade Name
- Disposable Hand Assist Tunnels EUDAMED
- Device Name
- Disposable Hand Assist Tunnels EUDAMED
- Model / Reference
- SQA60/70－60/150 EUDAMEDSQB70/60－35/50 EUDAMEDSQB50/40－25/25 EUDAMEDSQA180/190－180/250 EUDAMEDSQB50/40－15/20 EUDAMEDSQA320/330－320/250 EUDAMEDSQB60/50－25/25 EUDAMEDSQA80/90－80/150 EUDAMEDSQB60/50－25/50 EUDAMEDSQA270/280－270/250 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946480577165 EUDAMED06946480577127 EUDAMED06946480577059 EUDAMED06946480577110 EUDAMED06946480577097 EUDAMED06946480577141 EUDAMED06946480577028 EUDAMED06946480577158 EUDAMED06946480577011 EUDAMED06946480577080 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sinolinks Medical Innovation, Inc.
- EUDAMED SRN
- CN-MF-000010840
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (10)
- EUDAMED f2e6d2d2-6aa6-4dd8-bc6f-15cf76a138bc 61 fields · synced Oct 6, 2026
- EUDAMED b3775b93-5fb4-4808-ad76-e3ce6a75ade3 61 fields · synced May 16, 2026
- EUDAMED 9ae10231-3e3a-43a7-9490-734934a2fd63 61 fields · synced May 17, 2026
- EUDAMED bbb86cdf-a33c-4053-abb7-1b4dd79bb555 61 fields · synced May 17, 2026
- EUDAMED 43dcc2cb-b455-4706-a61c-ab1bf3515f76 61 fields · synced May 17, 2026
- EUDAMED f352e833-50ee-4c8c-965b-44e7465ed879 61 fields · synced May 17, 2026
- EUDAMED 2fca9762-ee3a-443b-bdd3-a4edd940a5c1 61 fields · synced May 18, 2026
- EUDAMED 4a24fc80-e87e-4859-b473-d219c68b6d7a 61 fields · synced May 18, 2026
- EUDAMED 527fded3-e72d-4c53-a7b0-34b15773625e 61 fields · synced May 18, 2026
- EUDAMED 0bc18933-0660-44a0-8f88-37a39af9abd0 61 fields · synced May 18, 2026