Identity
- Trade Name
- Blom-Singer Day&Night ClassicFlow EUDAMED
- Device Name
- DAY&NIGHT EUDAMED
- Model / Reference
- BE 1091 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00848253002071 EUDAMED
- Basic UDI-DI
- 08482530DAY&NIGHTVZ 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
Blom-Singer Day&Night ClassicFlow 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 | 08482530DAY&NIGHTVZ | 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 ca01354d-c28d-4846-ae36-3bd1453128cc 61 fields · synced Jun 18, 2026