Identity
- Trade Name
- PE Shoe Covers EUDAMED
- Device Name
- Shoe cover EUDAMED
- Model / Reference
- TM0802 EUDAMED8641 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974618410145 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 Covers 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 (1)
- EUDAMED 2fb14704-60fb-423c-bbec-788381aac3fb 61 fields · synced Jun 19, 2026