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N77a02
EUDAMEDClass I (EU MDR)
Ref N77A02Model Surgical Face Mask With Tie-On, Surgical Face Mask With Earloop, Children's Surgical Face Mask With Earloop, etc
Identity
- Model / Reference
- Surgical Face Mask With Tie-On, Surgical Face Mask With Earloop, Children's Surgical Face Mask With Earloop, etc EUDAMEDN77A02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974424843038 EUDAMED
- Basic UDI-DI
- 697442484L02Q9 EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR 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
N77a02 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 | 697442484L02Q9 | 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 06655c72-8974-411e-9b0c-a996d8788948 61 fields · synced Jun 18, 2026