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TriplePlay
EUDAMEDFDA UDIClass I (EU MDR)
Ref 10-40000-0550Model TriplePlay Airflow SensorsRef 10-10000-0410Ref 10-10000-0010Ref 10-10000-0610Ref 10-21001-0610Model AccuSnoreRef 12-40312-0001Ref 10-10000-0450Ref 10-10000-0210Ref 10-10000-0510Ref 10-10000-0050Ref 10-10000-0350Ref 10-10000-0250
Identity
- Trade Name
- TriplePlay EUDAMEDFDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- TriplePlan Airflow EUDAMEDAccuSnore Disposable Snore Sensors EUDAMEDFM5 - Alice 5 FDA UDI
- Model / Reference
- TriplePlay Airflow Sensors EUDAMED10-40000-0550 EUDAMED10-10000-0410 EUDAMED10-10000-0010 EUDAMED10-10000-0610 EUDAMEDAccuSnore EUDAMED10-21001-0610 EUDAMED12-40312-0001 EUDAMEDFDA UDI10-10000-0450 EUDAMED10-10000-0210 EUDAMED10-10000-0510 EUDAMED10-10000-0050 EUDAMED10-10000-0350 EUDAMED10-10000-0250 EUDAMED
- Description
- FM5 - Alice 5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20817377022924 EUDAMED10817377020039 EUDAMED10817377020008 EUDAMED10817377020053 EUDAMED10817377020114 EUDAMED00817377021190 EUDAMEDFDA UDI20817377020036 EUDAMED10817377020015 EUDAMED10817377020046 EUDAMED20817377020005 EUDAMED20817377020029 EUDAMED20817377020012 EUDAMED
- Basic UDI-DI
- 081737702101000064 EUDAMED08173770213100007B EUDAMED
- Direct Marketing DI
- 00817377021190 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 EUDAMEDSpain 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 (13)
- EUDAMED ef851a92-8170-47df-b7bb-476118ac7456 61 fields · synced Aug 4, 2026
- EUDAMED 817fc9be-6dc6-41e3-9b30-d92094588e5d 61 fields · synced May 16, 2026
- EUDAMED a39ff1d3-9606-494c-90de-785f3e02086e 61 fields · synced May 17, 2026
- EUDAMED 7cb53ede-3a3a-45f0-bf1e-c8b2879a6237 61 fields · synced May 17, 2026
- EUDAMED 90c2afec-cab0-43b3-b8c9-bc04de198c7d 61 fields · synced May 17, 2026
- EUDAMED b702a7e7-d261-4164-ad90-021c6158604a 61 fields · synced May 17, 2026
- EUDAMED 07063f11-c963-4484-a00c-20ff29583e15 61 fields · synced May 17, 2026
- EUDAMED 259ed168-e8e7-4cf8-bd1b-5b829d53bc6c 61 fields · synced May 17, 2026
- EUDAMED dec02b6d-21fb-4627-b083-8645755ec888 61 fields · synced May 18, 2026
- EUDAMED a305603b-0195-4d26-8c56-53b5b2e0a9a8 61 fields · synced May 18, 2026
- EUDAMED 3620c2ee-314d-442d-9657-b9038f39cfa6 61 fields · synced May 18, 2026
- EUDAMED b0b82a64-166c-4824-8475-d220c6e07efa 61 fields · synced May 19, 2026
- FDA UDI fc29515a-b172-47df-8f6c-df776e04c5b6 34 fields · synced May 30, 2026