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TriplePlay
EUDAMEDFDA UDIClass I (EU MDR)
Ref 12-40313-0001Model TriplePlay Airflow Sensors
Identity
- Trade Name
- TriplePlay EUDAMEDFDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- TriplePlan Airflow EUDAMEDFM5 - Alice 6 FDA UDI
- Model / Reference
- TriplePlay Airflow Sensors EUDAMED12-40313-0001 EUDAMEDFDA UDI
- Description
- FM5 - Alice 6 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817377021206 EUDAMEDFDA UDI
- Basic UDI-DI
- 081737702101000064 EUDAMED
- Direct Marketing DI
- 00817377021206 EUDAMED
- 510(k) Number
- K990321 FDA UDI
- FDA Product Code
- MNR FDA UDI
- EMDN Code
- Z12100585 POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Polysomnograph FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
TriplePlay by Dymedix Diagnostics, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081737702101000064 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dymedix Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000015691
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED fa9f72e1-3325-4c7c-a320-f9022df86309 61 fields · synced May 30, 2026
- FDA UDI 990367bb-771a-41e9-a58e-1762bb0183b4 34 fields · synced May 30, 2026