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Samozdrav COMFORT
EUDAMEDClass I (EU MDR)
Ref K01
by Limited Liability Company Research And Production Enterprise "samozdrav"
Identity
- Trade Name
- Samozdrav COMFORT EUDAMED
- Device Name
- Breathing training device EUDAMED
- Model / Reference
- K01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04607155710035 EUDAMED
- Basic UDI-DI
- 4607155711954ZA EUDAMED
- Direct Marketing DI
- 04607155710035 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 COMFORT by Limited Liability Company Research And Production Enterprise "samozdrav" — 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 — Henan Tuoren Medical Device Co., Ltd · Class IIa
- 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 | 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 2b6eed7c-4bab-4f06-8fb3-a1d38abf7799 61 fields · synced Oct 6, 2026