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TriplePlay
EUDAMEDClass I (EU MDR)
Ref 10-10000-0650Model TriplePlay Airflow Sensors
Identity
- Trade Name
- TriplePlay EUDAMED
- Device Name
- TriplePlan Airflow EUDAMED
- Model / Reference
- TriplePlay Airflow Sensors EUDAMED10-10000-0650 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20817377020050 EUDAMED
- Basic UDI-DI
- 081737702101000064 EUDAMED
- EMDN Code
- Z12100585 POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Portugal 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
TriplePlay by Dymedix Diagnostics, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 081737702101000064 | Class I | Active |
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Manufacturer
- Manufacturer
- Dymedix Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000015691
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED f798b195-f3da-4a3a-9c2f-091423b1aa24 61 fields · synced May 22, 2026