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N61a01-Gs05bm-B00
EUDAMEDClass I (EU MDR)
Ref N61A01-GS05BM-B00Model PP Isolation Gown
Identity
- Model / Reference
- PP Isolation Gown EUDAMEDN61A01-GS05BM-B00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974424846664 EUDAMED
- Basic UDI-DI
- 697442484L77R8 EUDAMED
- EMDN Code
- T020499 SURGICAL GOWNS - OTHER 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
N61a01-Gs05bm-B00 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 | 697442484L77R8 | 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 0242f8cb-473e-449e-a07f-05b6c39d41e5 61 fields · synced Oct 6, 2026