Identity
- Trade Name
- SKORE SHADES Red color with raised dots EUDAMED
- Device Name
- Condom EUDAMED
- Model / Reference
- DT01RF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906007136167 EUDAMED
- Basic UDI-DI
- B-08906007136167 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 SHADES Red color with raised dots by Ttk Healthcare Limited - Protective Devices Division — Class IIb — MDD — listed in EUDAMED
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-08906007136167 | 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 d2ea3424-716c-40a7-9372-958ca3efd3aa 61 fields · synced Jun 20, 2026