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Interventional Drape
EUDAMEDClass I (EU MDR)
Ref Interventional DrapeModel Interventional Drape、Pacemaker Drape with Single Aperture、Pacemaker Drape with Dual Apertures
Identity
- Model / Reference
- Interventional Drape、Pacemaker Drape with Single Aperture、Pacemaker Drape with Dual Apertures EUDAMEDInterventional Drape EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974424840907 EUDAMED
- Basic UDI-DI
- 697442484L86R9 EUDAMED
- EMDN Code
- T020102 SPECIALISTIC SURGERY DRAPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Interventional Drape by Leboo 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 | 697442484L86R9 | Class I | Active |
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Manufacturer
- Manufacturer
- Leboo Healthcare Products Limited
- EUDAMED SRN
- CN-MF-000008521
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 27d42b49-75f0-4172-b4e6-95c74c31db7b 61 fields · synced Oct 6, 2026