Identity
- Trade Name
- FastTrack Effort Belt EUDAMED
- Device Name
- FastTrack EUDAMED
- Model / Reference
- FastTrack EUDAMED11-44200-7510 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10817377023016 EUDAMED
- Basic UDI-DI
- 08173770211440008E 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
FastTrack Effort Belt by Dymedix Diagnostics, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Respiratory Effort Belts
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 | 08173770211440008E | 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 215589a8-1148-4a55-99ef-e7e606fcef01 61 fields · synced Jun 17, 2026