← Back to catalogue
FastTrack Effort Belt
EUDAMEDFDA UDIClass I (EU MDR)
Ref 11-44300-7550Model FastTrackRef 11-44100-7510Ref 11-44000-7540Ref 12-42017-0001Ref 11-44100-7550
Identity
- Trade Name
- FastTrack Effort Belt EUDAMEDPerfect Fit FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- FastTrack EUDAMEDInterface Cable, FastTrack, Chest, Alice 6 FDA UDI
- Model / Reference
- FastTrack EUDAMED11-44300-7550 EUDAMED11-44100-7510 EUDAMED11-44000-7540 EUDAMED12-42017-0001 EUDAMEDFDA UDI11-44100-7550 EUDAMED
- Description
- Interface Cable, FastTrack, Chest, Alice 6 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20817377023020 EUDAMED10817377023009 EUDAMED00817377022159 EUDAMED00817377022098 EUDAMEDFDA UDI20817377023006 EUDAMED
- Basic UDI-DI
- 08173770211440008E EUDAMED
- Direct Marketing DI
- 00817377022098 EUDAMED
- 510(k) Number
- K040605 FDA UDI
- FDA Product Code
- BZQ 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
FastTrack Effort Belt by Dymedix Diagnostics, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Manufacturer's product page: Respiratory Effort Belts
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 | 08173770211440008E | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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 (6)
- EUDAMED b408fa80-da58-411e-87b0-e3dc02a276db 61 fields · synced Jul 29, 2026
- EUDAMED 735bceed-1e23-481b-8454-dc4c22a32207 61 fields · synced May 17, 2026
- EUDAMED 11091136-4556-45f6-9f32-09e3685a5309 61 fields · synced May 17, 2026
- EUDAMED cf2b5633-a414-49b1-a016-d6eaf5169159 61 fields · synced May 17, 2026
- EUDAMED 612a10a1-1641-41b8-903c-76c93f0d845d 61 fields · synced May 17, 2026
- FDA UDI ff020652-40b8-4c3a-ba9d-26f3e3625425 34 fields · synced May 30, 2026