Identity
- Device Name
- Windi EUDAMED
- Model / Reference
- Windi EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350046331457 EUDAMED
- Basic UDI-DI
- 122000022PROJ7MZ EUDAMED
- Direct Marketing DI
- 07350046331457 EUDAMED
- EMDN Code
- G020301 RECTAL TUBES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
Windi by Fridababy, 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 | 122000022PROJ7MZ | Class I | Active |
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Manufacturer
- Manufacturer
- Fridababy, LLC
- EUDAMED SRN
- US-MF-000044395
- Authorised Representative
- Nasal Produkter Sverige AB SE-AR-000043090
Sources (1)
- EUDAMED 1203f38a-2b77-47b2-89f2-5e7c0c62a7f3 61 fields · synced Jul 9, 2026