Identity
- Trade Name
- Polymer Ligating Clip L Purple 13mm EUDAMED
- Device Name
- Polymer Ligating Clip L Purple 13mm EUDAMED
- Model / Reference
- PS35901 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051223036005 EUDAMED
- Basic UDI-DI
- B-05051223036005 EUDAMED
- EMDN Code
- H03030101 SINGULAR NON-ABSORBABLE HAEMOSTASIS CLIPS FOR OPEN SURGERY AND VIDEOSURGERY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Polymer Ligating Clip L Purple 13mm by Sinolinks Medical Innovation, Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05051223036005 | Class IIb | 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 e599570a-349c-4222-b3c1-0efca982c95b 61 fields · synced Jul 21, 2026