Identity
- Trade Name
- HOWDY BABY EUDAMED
- Device Name
- Howdy wearable monitoring solution EUDAMED
- Model / Reference
- CMF23EL01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053610200003 EUDAMED
- Basic UDI-DI
- 805361020CMFHOWDYM4 EUDAMED
- Direct Marketing DI
- 08053610200003 EUDAMED
- EMDN Code
- Z12039099 VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS – OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Howdy Baby by ComfTech — Class IIb — 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 | 805361020CMFHOWDYM4 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ComfTech
- EUDAMED SRN
- IT-MF-000028032
Sources (1)
- EUDAMED bf3cef9d-51b5-4b6b-8616-4e926986f832 61 fields · synced Jun 18, 2026