Identity
- Trade Name
- Penthrox EUDAMED
- Device Name
- Penthrox Inhaler EUDAMED
- Model / Reference
- ME-MS260-SE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09334258003355 EUDAMED
- Basic UDI-DI
- 9334258ME-759046E2 EUDAMED
- EMDN Code
- A99 DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Penthrox by Medical Developments International Limited — Class IIa — 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 | 9334258ME-759046E2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medical Developments International Limited
- EUDAMED SRN
- AU-MF-000013818
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 2f04f812-872d-4b72-acc9-3fbb3316e817 61 fields · synced Jun 18, 2026