Identity
- Trade Name
- UNIQ SMART EUDAMED
- Device Name
- UNIQ SMART EUDAMED
- Model / Reference
- 04260233385053 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260233385053 EUDAMED
- Basic UDI-DI
- B-04260233385053 EUDAMED
- EMDN Code
- U110101 CONDOMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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 Smart 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-04260233385053 | 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 9f413ff0-ec2a-415c-a757-f30305c6955c 61 fields · synced Jul 30, 2026