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Medical Face Mask
EUDAMEDClass I (EU MDR)
Ref MDRModel HONZ-SM-B/HONZ-SM-O/HONZ-M-O/HONZ-M-CL/HONZ-M-CS
Identity
- Device Name
- Medical Face Mask EUDAMED
- Model / Reference
- HONZ-SM-B/HONZ-SM-O/HONZ-M-O/HONZ-M-CL/HONZ-M-CS EUDAMEDMDR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06924993462963 EUDAMED
- Basic UDI-DI
- 692499340735365G EUDAMED
- EMDN Code
- R0301010202 NIV MASKS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Category: Rebreathing oxygen face mask
Medical Face Mask by Honz Pharmaceutical Co, .Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Rebreathing oxygen face mask.
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- Oro-Nasal Mask — HANS RUDOLPH, INC. · Class IIa
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 | 692499340735365G | Class I | Active |
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Manufacturer
- Manufacturer
- Honz Pharmaceutical Co, .Ltd.
- EUDAMED SRN
- CN-MF-000024508
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 5cf4a5ab-b42b-4625-8507-cc0911580f1a 61 fields · synced Jun 18, 2026