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N65c01-Ge012
EUDAMEDClass I (EU MDR)
Ref N65C01-GE012Model PP Sleeve Cover, Microporous Sleeve Cover, PE Coated Nonwoven Sleeve Cover, PE Sleeve Cover Machine Made, PE Sleeve Cover Hand Made, PVC Sleeve Cover, TPU Sleeve Cover and other customized specifications
Identity
- Model / Reference
- PP Sleeve Cover, Microporous Sleeve Cover, PE Coated Nonwoven Sleeve Cover, PE Sleeve Cover Machine Made, PE Sleeve Cover Hand Made, PVC Sleeve Cover, TPU Sleeve Cover and other customized specifications EUDAMEDN65C01-GE012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974424846497 EUDAMED
- Basic UDI-DI
- 697442484L09QP EUDAMED
- EMDN Code
- T0207 CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
N65c01-Ge012 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 | 697442484L09QP | 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 feb19519-4131-4cc2-a7f1-f88e82a105f3 61 fields · synced Oct 6, 2026