Identity
- Trade Name
- Plano Aproxima 1 EUDAMED
- Device Name
- NATURAL RUBBER MALE LATEX CONDOM EUDAMED
- Model / Reference
- APR201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 89043812010697 EUDAMED
- Basic UDI-DI
- 89043812MALELATEXCONDOMFU EUDAMED
- Direct Marketing DI
- 89043812010697 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
Plano Aproxima 1 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 aa9bde5a-4f31-4bf9-8242-d49622d88140 61 fields · synced Jun 19, 2026