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Samozdrav STANDARD
EUDAMEDClass I (EU MDR)
Ref C01
by Limited Liability Company Research And Production Enterprise "samozdrav"
Identity
- Trade Name
- Samozdrav STANDARD EUDAMED
- Device Name
- Breathing training device EUDAMED
- Model / Reference
- C01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04607155710028 EUDAMED
- Basic UDI-DI
- 4607155711954ZA EUDAMED
- Direct Marketing DI
- 04607155710028 EUDAMED
- EMDN Code
- R030199 RESPIRATORY MASKS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Samozdrav STANDARD by Limited Liability Company Research And Production Enterprise "samozdrav" — Class I — MDR — listed in EUDAMED
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Also classified as Anaesthesia face mask, single-use.
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- 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 | 4607155711954ZA | Class I | Active |
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Manufacturer
- EUDAMED SRN
- RU-MF-000034190
- Authorised Representative
- AFINA, spol.s r.o. CZ-AR-000000584
Sources (1)
- EUDAMED b0801fe1-e851-4fa4-b09d-5e76a374f949 61 fields · synced Aug 2, 2026