Identity
- Trade Name
- UNIQ FREE XL EUDAMED
- Device Name
- NON-LATEX MALE CONDOM EUDAMED
- Model / Reference
- 07708612425039 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07708612425039 EUDAMED
- Basic UDI-DI
- B-07708612425039 EUDAMED
- EMDN Code
- U110101 CONDOMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Finland 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Uniq Free Xl by Unique International Sas — 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-07708612425039 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Unique International Sas
- EUDAMED SRN
- CO-MF-000018348
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 2a153bca-23bc-4804-99ba-196264357d5e 61 fields · synced Jun 18, 2026