Identity
- Trade Name
- TriplePlay EUDAMED
- Device Name
- AccuSnore Disposable Snore Sensors EUDAMED
- Model / Reference
- AccuSnore EUDAMED10-21001-0650 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20817377020111 EUDAMED
- Basic UDI-DI
- 08173770213100007B 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 | 08173770213100007B | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dymedix Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000015691
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED 13c02cd6-cf9b-4fbd-a2c4-a74599ee3e28 61 fields · synced May 22, 2026