Identity
- Trade Name
- Fire Orange flavoured EUDAMED
- Device Name
- Fire Orange flavoured EUDAMED
- Model / Reference
- Dotted, (52±2)mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906016710051 EUDAMED
- Basic UDI-DI
- B-08906016710051 EUDAMED
- EMDN Code
- U110101 CONDOMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Fire Orange flavoured by MHL Healthcare Limited — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08906016710051 | Class IIb | Active |
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Manufacturer
- Manufacturer
- MHL Healthcare Limited
- EUDAMED SRN
- IN-MF-000007455
- Authorised Representative
- Meddevices Lifesciences B.V. NL-AR-000000594
Sources (2)
- EUDAMED 47bba94c-854d-4e62-a4c7-a758cf5e0c91 61 fields · synced Jun 18, 2026
- EUDAMED 47bba94c-854d-4e62-a4c7-a758cf5e0c91-1 61 fields · synced Jun 10, 2026