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TOCO Fetal transducer
EUDAMEDClass IIa (EU MDR)
Ref FTC-BN01Ref FTC-GD03Ref FTC-SL02Ref FTC-SC01Ref FTC-GE12Ref FTC-GD01Ref FTC-BA01Ref FTC-SL01Ref FTC-GE02Ref FTC-BT01Ref FTC-GE01Ref FTC-LK01Ref FTC-BC02Ref FTC-CM01Ref FTC-ED02Ref FTC-BC01Ref FTC-SU01Ref FTC-CM03Ref FTC-SC01-20Ref FTC-CM05Ref FTC-NT01Ref FTC-JP01Ref FTC-AL01
Identity
- Trade Name
- TOCO Fetal transducer EUDAMED
- Device Name
- TOCO Fetal transducer EUDAMED
- Model / Reference
- FTC-BN01 EUDAMEDFTC-GD03 EUDAMEDFTC-SL02 EUDAMEDFTC-SC01 EUDAMEDFTC-GE12 EUDAMEDFTC-GD01 EUDAMEDFTC-BA01 EUDAMEDFTC-SL01 EUDAMEDFTC-GE02 EUDAMEDFTC-BT01 EUDAMEDFTC-GE01 EUDAMEDFTC-LK01 EUDAMEDFTC-BC02 EUDAMEDFTC-CM01 EUDAMEDFTC-ED02 EUDAMEDFTC-BC01 EUDAMEDFTC-SU01 EUDAMEDFTC-CM03 EUDAMEDFTC-SC01-20 EUDAMEDFTC-CM05 EUDAMEDFTC-NT01 EUDAMEDFTC-JP01 EUDAMEDFTC-AL01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941691955535 EUDAMED06941691973218 EUDAMED06970706360620 EUDAMED06970706360583 EUDAMED06941691985518 EUDAMED06941691973201 EUDAMED06941691973249 EUDAMED06970706360613 EUDAMED06970706360569 EUDAMED06941691955559 EUDAMED06970706360552 EUDAMED06941691973232 EUDAMED06941691973256 EUDAMED06941691973188 EUDAMED06941691963073 EUDAMED06941691973263 EUDAMED06941691965848 EUDAMED06941691973195 EUDAMED06941691977698 EUDAMED06941691974567 EUDAMED06941691955528 EUDAMED06941691973225 EUDAMED06970706360576 EUDAMED
- Basic UDI-DI
- B-06941691955535 EUDAMEDB-06941691973218 EUDAMEDB-06970706360620 EUDAMEDB-06970706360583 EUDAMEDB-06941691985518 EUDAMEDB-06941691973201 EUDAMEDB-06941691973249 EUDAMEDB-06970706360613 EUDAMEDB-06970706360569 EUDAMEDB-06941691955559 EUDAMEDB-06970706360552 EUDAMEDB-06941691973232 EUDAMEDB-06941691973256 EUDAMEDB-06941691973188 EUDAMEDB-06941691963073 EUDAMEDB-06941691973263 EUDAMEDB-06941691965848 EUDAMEDB-06941691973195 EUDAMEDB-06941691977698 EUDAMEDB-06941691974567 EUDAMEDB-06941691955528 EUDAMEDB-06941691973225 EUDAMEDB-06970706360576 EUDAMED
- EMDN Code
- Z12080101 FOETAL MONITORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMEDEUDAMED
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
Yes
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
TOCO Fetal transducer by Orantech Inc. — Class IIa — 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-06941691955535 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Orantech Inc.
- EUDAMED SRN
- CN-MF-000013859
- Authorised Representative
- Medten EU ApS DK-AR-000034434
Sources (23)
- EUDAMED f8404be9-b756-4b67-9be6-903d585d4178 61 fields · synced Sep 18, 2026
- EUDAMED 819b15bf-0ca2-49e1-9cb5-b79faa5df258 61 fields · synced May 16, 2026
- EUDAMED c244caaa-c98f-4b15-9c89-2a01669a3d90 61 fields · synced May 16, 2026
- EUDAMED 8afc14e3-cc61-40e3-983d-fa228aac0346 61 fields · synced May 17, 2026
- EUDAMED 1462fb09-468b-4595-9095-6f523bebef9c 61 fields · synced May 17, 2026
- EUDAMED c9ab2c49-e726-4c19-a6da-9d10692c527a 61 fields · synced May 17, 2026
- EUDAMED db7d69a8-abf7-4697-93ae-84f0cad89848 61 fields · synced May 17, 2026
- EUDAMED 2faa8062-992e-4eb8-a7d6-da04c283b035 61 fields · synced May 17, 2026
- EUDAMED 21a48850-75d8-4faf-84bb-1e16e1ad1ae4 61 fields · synced May 17, 2026
- EUDAMED 2eb18fce-c026-4dfa-b74c-c033c110ec7a 61 fields · synced May 17, 2026
- EUDAMED 3a4d2ff0-a3ad-461b-9f46-375f13c9f0c5 61 fields · synced May 17, 2026
- EUDAMED 1d8201a6-c1a9-41fa-8896-9d2aacd018c5 61 fields · synced May 17, 2026
- EUDAMED 17ed89d7-de1d-4ed5-9faa-8004b4ccf974 61 fields · synced May 17, 2026
- EUDAMED a401d75e-19a9-4e21-bae8-6817442706e7 61 fields · synced May 17, 2026
- EUDAMED 5f7aa43a-fc39-418c-b855-c68782295c85 61 fields · synced May 17, 2026
- EUDAMED 48a61652-4465-466c-abe3-2166d15c2a58 61 fields · synced May 18, 2026
- EUDAMED 12639dfe-8fea-4623-b33e-c67cf01389be 61 fields · synced May 18, 2026
- EUDAMED 6ca3980e-1a51-4316-bcde-8f2beacb1ff0 61 fields · synced May 18, 2026
- EUDAMED ad0a02ad-a06a-48f3-8bfa-a7e6d90c0e78 61 fields · synced May 18, 2026
- EUDAMED c8e9cca1-4720-4116-ae97-d23c2a9014ef 61 fields · synced May 18, 2026
- EUDAMED 51783d4b-7516-4df0-9a2e-b20593028f85 61 fields · synced May 18, 2026
- EUDAMED efbea030-c377-4da9-a7cb-bc6f1308a7ea 61 fields · synced May 18, 2026
- EUDAMED c95c7aa3-041b-455f-aa47-47de35b18a3c 61 fields · synced May 19, 2026