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Boot Covers
EUDAMEDClass I (EU MDR)
Ref XB15E01Model XB12N01, XB12N02, XB12N03, XB15E01
Identity
- Device Name
- Boot Covers EUDAMED
- Model / Reference
- XB12N01, XB12N02, XB12N03, XB15E01 EUDAMEDXB15E01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976800671006 EUDAMED
- Basic UDI-DI
- 697680067BootCoversD3 EUDAMED
- EMDN Code
- T0208 SHOE COVERS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Boot Covers by Sinopharm Fortune International Trading Corp. — 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 | 697680067BootCoversD3 | Class I | Active |
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Manufacturer
- Manufacturer
- Sinopharm Fortune International Trading Corp.
- EUDAMED SRN
- CN-MF-000038309
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 9e7bf06e-477f-46a9-b0a4-3b330797a365 61 fields · synced Jun 19, 2026