Identity
- Trade Name
- PE shoe cover EUDAMED
- Device Name
- Shoe cover EUDAMED
- Model / Reference
- TM0802 EUDAMED8645 EUDAMED8641A EUDAMED8636A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974618410169 EUDAMED06974618411388 EUDAMED06974618411524 EUDAMED
- Basic UDI-DI
- 697461841TM0802JX EUDAMED
- EMDN Code
- T0208 SHOE COVERS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
PE shoe cover by Ningbo Transo-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 | 697461841TM0802JX | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Transo-Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000009687
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (3)
- EUDAMED b5294292-cf95-48b9-8256-6c0368025d83 61 fields · synced Jul 17, 2026
- EUDAMED 1b43e75f-b4a3-4c2e-b295-8e507277bbbf 61 fields · synced Jun 20, 2026
- EUDAMED beee2709-4c4b-43a3-82af-f60ed3a13493 61 fields · synced Jul 9, 2026