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Manforce Condom Dotted
EUDAMEDClass IIb (EU MDR)
Ref PL/DR/PR/002Model 53±2mm Dotted Textured
Identity
- Trade Name
- Manforce Condom Dotted EUDAMED
- Device Name
- Male Latex Condom EUDAMED
- Model / Reference
- 53±2mm Dotted Textured EUDAMEDPL/DR/PR/002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08905782000236 EUDAMED
- Basic UDI-DI
- B-08905782000236 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
Manforce Condom Dotted by Penta Latex Llp — 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-08905782000236 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Penta Latex Llp
- EUDAMED SRN
- IN-MF-000022836
- Authorised Representative
- Meddevices Lifesciences B.V. NL-AR-000000594
Sources (1)
- EUDAMED 0960e5fe-42ed-42d2-9076-200791d2d38b 61 fields · synced Jun 18, 2026