Identity
- Trade Name
- SKORE COOL Watermelon EUDAMED
- Device Name
- Condom EUDAMED
- Model / Reference
- DT01RF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906007136044 EUDAMED
- Basic UDI-DI
- B-08906007136044 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 COOL Watermelon 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-08906007136044 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ttk Healthcare Limited - Protective Devices Division
- EUDAMED SRN
- IN-MF-000008508
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED 6bf44f33-482b-4de5-bb68-70ff68d76762 61 fields · synced Jun 18, 2026