Identity
- Trade Name
- SpeakFree HME ClassicFlow, 6 pack EUDAMED
- Device Name
- SPEAKFREE EUDAMED
- Model / Reference
- BE 1090EZ-6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00848253002279 EUDAMED
- Basic UDI-DI
- 08482530SPEAKFREEGJ EUDAMED
- EMDN Code
- R040201 TRACHEOSTOMY HUMIDIFIERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
SpeakFree HME ClassicFlow, 6 pack by Freudenberg Medical LLC — Class I — 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 | 08482530SPEAKFREEGJ | Class I | Active |
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Manufacturer
- Manufacturer
- Freudenberg Medical LLC
- EUDAMED SRN
- US-MF-000023823
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 95af399f-f7cd-46cb-87e5-2c6258e8325c 61 fields · synced Jun 19, 2026