Identity
- Trade Name
- SKORE Orange EUDAMED
- Device Name
- Condom EUDAMED
- Model / Reference
- DT01O EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906007136440 EUDAMED
- Basic UDI-DI
- B-08906007136440 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
SKORE Orange by Ttk Healthcare Limited - Protective Devices Division — 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-08906007136440 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Ttk Healthcare Limited - Protective Devices Division
- EUDAMED SRN
- IN-MF-000008508
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED f7458b80-0698-4917-a4d4-24e909d74e0c 61 fields · synced Jul 13, 2026