Identity
- Model / Reference
- E.N.T. Drape EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975197849500 EUDAMED
- Basic UDI-DI
- 697519784Z80WX EUDAMED
- EMDN Code
- T020102 SPECIALISTIC SURGERY DRAPES 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
E.N.T. Drape by Leboo (Hubei) Healthcare Products Limited — 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 | 697519784Z80WX | Class I | Active |
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Manufacturer
- Manufacturer
- Leboo (Hubei) Healthcare Products Limited
- EUDAMED SRN
- CN-MF-000021186
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED ecbe33b0-b19d-41a4-9369-8dd8a0efeb5a 61 fields · synced Oct 6, 2026