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Cu375 Sleek
EUDAMEDClass III (EU MDR)
Ref CL29Model Intrauterine Contraceptive Device
Identity
- Trade Name
- Cu375 Sleek EUDAMED
- Device Name
- Cu 375 Sleek EUDAMED
- Model / Reference
- Intrauterine Contraceptive Device EUDAMEDCL29 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906028600098 EUDAMED
- Basic UDI-DI
- B-08906028600098 EUDAMED
- EMDN Code
- U110201 INTRAUTERINE COILS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
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
Yes
EUDAMED
Cu375 Sleek by SMB Corporation of India — Class III — 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-08906028600098 | Class III | Active |
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Manufacturer
- Manufacturer
- SMB Corporation of India
- EUDAMED SRN
- IN-MF-000023742
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 68dd22cf-038b-4a05-91bb-dc8134079092 61 fields · synced Jul 15, 2026