Identity
- Trade Name
- ETOS Second Skin EUDAMED
- Device Name
- Condom EUDAMED
- Model / Reference
- MT06 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906007137263 EUDAMED
- Basic UDI-DI
- B-08906007137263 EUDAMED
- EMDN Code
- U110101 CONDOMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands 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
ETOS Second Skin 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-08906007137263 | 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 584f7471-1b6d-41f0-a244-3fdb343f70c4 61 fields · synced Jun 19, 2026