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Penthrox
EUDAMEDClass IIa (EU MDR)
Ref ME-MS260-GAL-IRERef ME-MS260-HRSIRef ME-MS260-CZRef ME-MS260-ETH-FR
Identity
- Trade Name
- Penthrox EUDAMED
- Device Name
- Penthrox Inhaler EUDAMED
- Model / Reference
- ME-MS260-GAL-IRE EUDAMEDME-MS260-HRSI EUDAMEDME-MS260-CZ EUDAMEDME-MS260-ETH-FR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09334258003324 EUDAMED09334258003409 EUDAMED09334258003386 EUDAMED09334258003317 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
- Ireland EUDAMEDCroatia EUDAMEDCzechia EUDAMEDFrance 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 (7)
- EUDAMED a94d863c-fa4f-449b-9ff5-f4e6eacd2674 61 fields · synced Aug 4, 2026
- EUDAMED 416ad571-edb4-44af-bf4b-84313f9039bf 61 fields · synced May 17, 2026
- EUDAMED 733e2348-a6a4-4018-8efa-73eae5bd43c2 61 fields · synced May 18, 2026
- EUDAMED 9e234111-94b2-446f-8417-b9eaf10bc000 61 fields · synced May 19, 2026
- EUDAMED 4606476e-4b7c-4ba4-824f-d92c7553788e 61 fields · synced Jul 10, 2026
- EUDAMED 5da7f157-d32f-4b83-9263-435615594b9f 61 fields · synced Aug 3, 2026
- EUDAMED 52414f9c-71c7-4fc3-8d74-2ea210d4680f 61 fields · synced Aug 4, 2026