Identity
- Trade Name
- OPTIFLOW EUDAMED
- Device Name
- OPTIFLOW EUDAMED
- Model / Reference
- 63.00.100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640109052154 EUDAMED
- Basic UDI-DI
- B-07640109052154 EUDAMED
- EMDN Code
- V020302 BABY BOTTLES AND KIT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Optiflow by Ardo medical AG — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07640109052154 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ardo medical AG
- EUDAMED SRN
- CH-MF-000016526
- Authorised Representative
- ARDO medical GmbH DE-AR-000014440
Sources (1)
- EUDAMED 86ae7da7-1267-4aee-a522-19a828e571fb 61 fields · synced Jun 18, 2026