Identity
- Trade Name
- Etos Extra Glide x 12 EUDAMED
- Device Name
- NATURAL RUBBER MALE LATEX CONDOM EUDAMED
- Model / Reference
- ETO233 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 89043812010390 EUDAMED
- Basic UDI-DI
- 89043812MALELATEXCONDOMFU EUDAMED
- Direct Marketing DI
- 89043812010390 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Etos Extra Glide x 12 by Indus Medicare Limited — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 89043812MALELATEXCONDOMFU | Class IIb | Active |
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Manufacturer
- Manufacturer
- Indus Medicare Limited
- EUDAMED SRN
- IN-MF-000008912
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED b1f7db48-f2e2-4fcb-8293-c77b88c95c49 61 fields · synced Jul 20, 2026