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Natural rubber latex male condoms
EUDAMEDClass IIb (EU MDR)
Ref 55mmModel small size (49±2mm) , medium size (53mm±2mm), large size (55mm±2mm), extra-large size (58mm±2mm); Smooth, Studs, RibsModel small size (nominal width 49mm) , medium size (nominal width 52mm), large size (nominal width 55mm)Ref 53mm
Identity
- Trade Name
- Natural rubber latex male condoms EUDAMED
- Device Name
- Male Latex Condoms EUDAMED
- Model / Reference
- small size (49±2mm) , medium size (53mm±2mm), large size (55mm±2mm), extra-large size (58mm±2mm); Smooth, Studs, Ribs EUDAMED55mm EUDAMEDsmall size (nominal width 49mm) , medium size (nominal width 52mm), large size (nominal width 55mm) EUDAMED53mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925634024175 EUDAMED06925634022287 EUDAMED06925634024168 EUDAMED06925634024144 EUDAMED06925634024182 EUDAMED
- Basic UDI-DI
- 69256340MLC3H EUDAMEDB-06925634022287 EUDAMED
- Direct Marketing DI
- 06925634024175 EUDAMED06925634024168 EUDAMED06925634024144 EUDAMED06925634024182 EUDAMED
- EMDN Code
- U110101 CONDOMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Natural rubber latex male condoms by Suzhou Colour-way New Material Co., Ltd. — Class IIb — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69256340MLC3H | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | 69256340MLC3H | Class IIb | Active |
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Manufacturer
- Manufacturer
- Suzhou Colour-way New Material Co., Ltd.
- EUDAMED SRN
- CN-MF-000027396
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (5)
- EUDAMED 39f54afd-27eb-43bf-9008-78620e1123f7 61 fields · synced Jul 29, 2026
- EUDAMED 72b3d3f3-4342-4d49-9eda-b4044ea8c50d 61 fields · synced May 16, 2026
- EUDAMED 97aba6e2-ccee-48a6-9443-6bb7cfdcb558 61 fields · synced May 16, 2026
- EUDAMED b31b09a0-be24-43a0-8319-b7d127859725 61 fields · synced May 17, 2026
- EUDAMED 7743afff-ea6a-46ba-8c7a-bf1f070dcc7d 61 fields · synced May 19, 2026