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Sutures adhésives stériles
EUDAMEDClass I (EU MDR)
Ref 190855Ref 190856Ref 147416Ref 147499
Identity
- Trade Name
- Sutures adhésives stériles EUDAMED
- Device Name
- Wound Closure Strip EUDAMED
- Model / Reference
- 190855 EUDAMED190856 EUDAMED147416 EUDAMED147499 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926515491109 EUDAMED06926515491147 EUDAMED06926515491260 EUDAMED06926515491222 EUDAMED
- Basic UDI-DI
- 69593857SCS000001GK EUDAMED
- EMDN Code
- H900102 BANDAGES FOR SUTURES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Sutures adhésives stériles by Zhende Medical Co., Ltd. — Class I — 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 | 69593857SCS000001GK | Class I | Active |
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Manufacturer
- Manufacturer
- Zhende Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000009961
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (4)
- EUDAMED 42f58f3b-c5b6-4fe7-9e0a-49cf4e1fb418 61 fields · synced Jul 14, 2026
- EUDAMED f92f8117-171e-4877-ba52-77c3d2ed8d0e 61 fields · synced May 16, 2026
- EUDAMED bd73cf41-e945-4e9f-9963-06340b0c3765 61 fields · synced May 17, 2026
- EUDAMED b26935e1-836d-4d61-a612-4459e1261022 61 fields · synced May 18, 2026