Identity
- Device Name
- Pocket size respiratory mask EUDAMED
- Model / Reference
- 10034.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04745010564086 EUDAMED
- Basic UDI-DI
- 474501056410034BH EUDAMED
- EMDN Code
- R030199 RESPIRATORY MASKS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Estonia 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: Anaesthesia face mask, single-use
Pocket size respiratory mask by 1m4 Oü — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Anaesthesia face mask, single-use.
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- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- King Mask — Ambu A/S · Class I
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 | 474501056410034BH | Class I | Active |
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Manufacturer
- Manufacturer
- 1m4 Oü
- EUDAMED SRN
- EE-MF-000040367
Sources (1)
- EUDAMED aca41819-a990-4f16-81b4-80dc2154403f 61 fields · synced Jun 19, 2026