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Ty-N62j01-Os15gd-B10
EUDAMEDClass I (EU MDR)
Ref TY-N62J01-OS15GD-B10Model Face Mask With Shield, Dust Mask, Carbon Face Mask, Face Mask With Tie-On, Face Mask With Earloop, Children Face Mask With Earloop, Paper Face Mask and other customized specifications
Identity
- Model / Reference
- Face Mask With Shield, Dust Mask, Carbon Face Mask, Face Mask With Tie-On, Face Mask With Earloop, Children Face Mask With Earloop, Paper Face Mask and other customized specifications EUDAMEDTY-N62J01-OS15GD-B10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974424845131 EUDAMED
- Basic UDI-DI
- 697442484L01Q7 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
Ty-N62j01-Os15gd-B10 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 | 697442484L01Q7 | 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 f97fca1e-c297-4c58-9dbd-2b81d27130aa 61 fields · synced Oct 6, 2026