Identity
- Trade Name
- Wakeeta EUDAMED
- Device Name
- Tiotropium Bromide Inhalation Device EUDAMED
- Model / Reference
- Not Applicable for Wakeeta device EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-8901117WAK0123MUSF EUDAMED
- Basic UDI-DI
- B-8901117WAK0123MUSF EUDAMED
- EMDN Code
- R9001 RESPIRATORY MOUTHPIECES EUDAMED
Classification
- Device Class
- Class I 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Wakeeta by Cipla Limited — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union No Longer Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-8901117WAK0123MUSF | Class I | No Longer Active |
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Manufacturer
- Manufacturer
- Cipla Limited
- EUDAMED SRN
- IN-MF-000038939
- Authorised Representative
- Cipla Europe NV BE-AR-000038918
Sources (1)
- EUDAMED 5a8f11fe-58a0-473d-9704-a83529e917cf 61 fields · synced Jul 10, 2026