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N65c01
EUDAMEDFDA UDIClass I (EU MDR)
Ref N65C01Model 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
- Trade Name
- LEBOO FDA UDI
- Generic Name
- Surgical sleeve cover FDA UDI
- 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 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974424840174 EUDAMED06974424845674 FDA UDI
- Basic UDI-DI
- 697442484L09QP EUDAMED
- FDA Product Code
- LYU FDA UDI
- EMDN Code
- T0207 CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
- GMDN Term
- Surgical sleeve cover FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
N65c01 by Leboo Healthcare Products Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697442484L09QP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 b6d6ce5a-c03f-4ed5-a699-7c7026933dda 61 fields · synced Jun 18, 2026
- FDA UDI b87cbab7-4862-4157-9a2d-95d5a3a6ad60 32 fields · synced May 30, 2026