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TCu380 Plus Normal
EUDAMEDClass III (EU MDR)
Ref PN31Model INTRAUTERINE CONTRACEPTIVE DEVICE
Identity
- Trade Name
- TCu380 Plus Normal EUDAMED
- Device Name
- TCu380 Plus Normal EUDAMED
- Model / Reference
- INTRAUTERINE CONTRACEPTIVE DEVICE EUDAMEDPN31 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906028600067 EUDAMED
- Basic UDI-DI
- B-08906028600067 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
TCu380 Plus Normal 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-08906028600067 | 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 d8157c14-13a3-42b3-8cdb-1a503d916189 61 fields · synced Jun 19, 2026