← Back to catalogue
N61c01-Lreg-008
EUDAMEDClass I (EU MDR)
Ref N61C01-LREG-008Model Coverall, Split Coverall, Type56B Coverall and other customized specifications
Identity
- Model / Reference
- Coverall, Split Coverall, Type56B Coverall and other customized specifications EUDAMEDN61C01-LREG-008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974424847883 EUDAMED
- Basic UDI-DI
- 697442484L04QD EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER 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
N61c01-Lreg-008 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 | 697442484L04QD | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Leboo Healthcare Products Limited
- EUDAMED SRN
- CN-MF-000008521
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 351ad64e-66a9-44ed-b8a5-d5fa3b637ef7 61 fields · synced Oct 6, 2026