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Cardiovascular Drape
EUDAMEDClass I (EU MDR)
Ref Cardiovascular DrapeModel Cardiovascular (CABG) Drape、Cardiovascular DrapeRef Cardiovascular (CABG) Drape
Identity
- Model / Reference
- Cardiovascular (CABG) Drape、Cardiovascular Drape EUDAMEDCardiovascular Drape EUDAMEDCardiovascular (CABG) Drape EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974424840945 EUDAMED06974424840938 EUDAMED
- Basic UDI-DI
- 697442484L87RB 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
Cardiovascular 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 | 697442484L87RB | 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 (2)
- EUDAMED 183e0e9e-a167-4f0d-8aa5-07193526b5c0 61 fields · synced Oct 6, 2026
- EUDAMED 0a7d6645-ef59-4559-86db-2f54c7b664a2 61 fields · synced May 19, 2026