Identity
- Trade Name
- Aseptika Limited EUDAMED
- Device Name
- PUFFClicker Inhaler Dose Counter Accessory for Trimbow pMDI EUDAMED
- Model / Reference
- P167/P105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060293171103 EUDAMED
- Basic UDI-DI
- 5060293171103SY EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER 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
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
Aseptika Limited by Aseptika Limited — 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 | 5060293171103SY | Class I | Active |
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Manufacturer
- Manufacturer
- Aseptika Limited
- EUDAMED SRN
- UK-MF-000037607
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (1)
- EUDAMED e1159783-4c1b-46e7-8469-7ba7463b9c81 61 fields · synced Jun 19, 2026