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TCu380A
EUDAMEDClass III (EU MDR)
Ref N32Model Intrauterine Contraceptive Device
Identity
- Trade Name
- TCu380A EUDAMED
- Device Name
- Copper T 380A (TCu 380A / CuT380A) EUDAMED
- Model / Reference
- Intrauterine Contraceptive Device EUDAMEDN32 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906028600012 EUDAMED
- Basic UDI-DI
- B-08906028600012 EUDAMED
- EMDN Code
- U110201 INTRAUTERINE COILS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Poland 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
TCu380A 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-08906028600012 | 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 c1ba392d-89dc-44fa-b4e2-03d7c58d15d1 61 fields · synced Jul 19, 2026