Identity
- Trade Name
- Sutures adhésives stériles EUDAMED
- Device Name
- Wound Closure Strip EUDAMED
- Model / Reference
- 190857 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926515491185 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 (1)
- EUDAMED 27287f24-3968-4540-be7b-7dee06b090d9 61 fields · synced Jun 19, 2026