Identity
- Trade Name
- Sleep apnea screen meter EUDAMED
- Device Name
- Sleep apnea screen meter EUDAMED
- Model / Reference
- RS01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945040101154 EUDAMED
- Basic UDI-DI
- 69450401RS01QA EUDAMED
- Direct Marketing DI
- 06945040101154 EUDAMED
- EMDN Code
- Z12030299 VITAL SIGNS MONITORING INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Electrical-only medical device connection cable, reusable
Sleep apnea screen meter by Contec Medical Systems Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69450401RS01QA | Class IIa | Active |
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Manufacturer
- Manufacturer
- Contec Medical Systems Co., Ltd.
- EUDAMED SRN
- CN-MF-000007715
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 8a26c818-9a90-498b-a656-03751e9d730d 61 fields · synced Jun 19, 2026