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Respiratory Compression Belt
EUDAMEDClass I (EU MDR)
Ref 60-312Model Respiratory Compression Belt
Identity
- Trade Name
- Respiratory Compression Belt EUDAMED
- Device Name
- Respiratory Compression Belt Small EUDAMED
- Model / Reference
- Respiratory Compression Belt EUDAMED60-312 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B365603120 EUDAMED
- Basic UDI-DI
- ++B36560300FL EUDAMED
- Direct Marketing DI
- +B365603120 EUDAMED
- EMDN Code
- Z11010199 LINEAR ACCELERATORS – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Respiratory Compression Belt by Aktina Medical Corp — Class I — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Respiratory Compression Belt
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 | ++B36560300FL | Class I | Active |
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Manufacturer
- Manufacturer
- Aktina Medical Corp
- EUDAMED SRN
- US-MF-000005935
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (1)
- EUDAMED e7147aaf-b9de-4db2-a66c-acf8e61fd6b7 61 fields · synced Oct 6, 2026