Identity
- Trade Name
- Fixation PE transparent tape EUDAMED
- Device Name
- Medical Adhesive Tape EUDAMED
- Model / Reference
- MAD2016NA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942273361911 EUDAMED
- Basic UDI-DI
- 69593857MT000001WX EUDAMED
- EMDN Code
- M04010201 NON-WOVEN FIXING DRESSINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
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
Fixation PE transparent tape 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 | 69593857MT000001WX | 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 60e8988e-39d2-4a83-b182-bed7ba0f3388 61 fields · synced Jun 17, 2026