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Ultrasound Fetal transducer
EUDAMEDClass IIa (EU MDR)
Ref FUS-AL02Ref FUS-BA01Ref FUS-SC03Ref FUS-SC04Ref FUS-CM03Ref FUSTC-CT02Ref FUSTC-CT01Ref FUSTC-GD03Ref FUS-CM01Ref FUS-ED02Ref FUS-ED03Ref FUS-SU01Ref FUS-TY01Ref FUS-GE12Ref FUS-CM06Ref FUS-GD05Ref FUSTC-LK01Ref FUS-GE02Ref FUS-BL01Ref FUSTC-TY01Ref FUSTC-GD01Ref FUS-SL02Ref FUS-BC02Ref FUS-SC04-20Ref FUS-SC05Ref FUS-GD04Ref FUS-SC01Ref FUS-GE03Ref FUS-GE02SRef FUS-BC01Ref FUS-CM04Ref FUS-BT01Ref FUS-AL03
Identity
- Trade Name
- Ultrasound Fetal transducer EUDAMED
- Device Name
- Ultrasound Fetal transducer EUDAMED
- Model / Reference
- FUS-AL02 EUDAMEDFUS-BA01 EUDAMEDFUS-SC03 EUDAMEDFUS-SC04 EUDAMEDFUS-CM03 EUDAMEDFUSTC-CT02 EUDAMEDFUSTC-CT01 EUDAMEDFUSTC-GD03 EUDAMEDFUS-CM01 EUDAMEDFUS-ED02 EUDAMEDFUS-ED03 EUDAMEDFUS-SU01 EUDAMEDFUS-TY01 EUDAMEDFUS-GE12 EUDAMEDFUS-CM06 EUDAMEDFUS-GD05 EUDAMEDFUSTC-LK01 EUDAMEDFUS-GE02 EUDAMEDFUS-BL01 EUDAMEDFUSTC-TY01 EUDAMEDFUSTC-GD01 EUDAMEDFUS-SL02 EUDAMEDFUS-BC02 EUDAMEDFUS-SC04-20 EUDAMEDFUS-SC05 EUDAMEDFUS-GD04 EUDAMEDFUS-SC01 EUDAMEDFUS-GE03 EUDAMEDFUS-GE02S EUDAMEDFUS-BC01 EUDAMEDFUS-CM04 EUDAMEDFUS-BT01 EUDAMEDFUS-AL03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970706360507 EUDAMED06941691973126 EUDAMED06970706360484 EUDAMED06970706360521 EUDAMED06941691973027 EUDAMED06941691973379 EUDAMED06941691973294 EUDAMED06941691973324 EUDAMED06941691973003 EUDAMED06970706360538 EUDAMED06941691973041 EUDAMED06941691965855 EUDAMED06941691973119 EUDAMED06941691985501 EUDAMED06941691981060 EUDAMED06941691966661 EUDAMED06941691973348 EUDAMED06970706360415 EUDAMED06941691973171 EUDAMED06941691973355 EUDAMED06941691973300 EUDAMED06970706360439 EUDAMED06941691973133 EUDAMED06941691982647 EUDAMED06941691973164 EUDAMED06941691973072 EUDAMED06970706360453 EUDAMED06941691981268 EUDAMED06941691973720 EUDAMED06941691973140 EUDAMED06941691973034 EUDAMED06941691955511 EUDAMED06970706360514 EUDAMED
- Basic UDI-DI
- B-06970706360507 EUDAMEDB-06941691973126 EUDAMEDB-06970706360484 EUDAMEDB-06970706360521 EUDAMEDB-06941691973027 EUDAMEDB-06941691973379 EUDAMEDB-06941691973294 EUDAMEDB-06941691973324 EUDAMEDB-06941691973003 EUDAMEDB-06970706360538 EUDAMEDB-06941691973041 EUDAMEDB-06941691965855 EUDAMEDB-06941691973119 EUDAMEDB-06941691985501 EUDAMEDB-06941691981060 EUDAMEDB-06941691966661 EUDAMEDB-06941691973348 EUDAMEDB-06970706360415 EUDAMEDB-06941691973171 EUDAMEDB-06941691973355 EUDAMEDB-06941691973300 EUDAMEDB-06970706360439 EUDAMEDB-06941691973133 EUDAMEDB-06941691982647 EUDAMEDB-06941691973164 EUDAMEDB-06941691973072 EUDAMEDB-06970706360453 EUDAMEDB-06941691981268 EUDAMEDB-06941691973720 EUDAMEDB-06941691973140 EUDAMEDB-06941691973034 EUDAMEDB-06941691955511 EUDAMEDB-06970706360514 EUDAMED
- EMDN Code
- Z12080101 FOETAL MONITORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass IIb 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
Ultrasound 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-06970706360507 | 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 (33)
- EUDAMED 329b1a8c-4ace-4062-9f8b-aef97cb1b890 61 fields · synced Aug 1, 2026
- EUDAMED 4ec5d937-e1f2-4062-95b2-72a9ad9c9772 61 fields · synced May 16, 2026
- EUDAMED 2b9372e8-fbbe-46e8-a1e2-a9da874d6282 61 fields · synced May 16, 2026
- EUDAMED be05f5c1-df5e-4a4d-aec6-e34b179c08f4 61 fields · synced May 17, 2026
- EUDAMED f5361650-ad9a-43b2-824a-24bc6b026f14 61 fields · synced May 17, 2026
- EUDAMED 3cb4de2b-2b20-4e8a-95af-46ecb11ba511 61 fields · synced May 17, 2026
- EUDAMED 5b4f4ca7-d372-4197-8bb8-003bfc651d09 61 fields · synced May 17, 2026
- EUDAMED 995a861f-e20b-4794-9340-9aecab072f24 61 fields · synced May 17, 2026
- EUDAMED 112618ad-2cdb-44b1-bc53-d7aee6847ab5 61 fields · synced May 17, 2026
- EUDAMED b6a1ce26-d705-463a-9334-8d52ea838d1c 61 fields · synced May 17, 2026
- EUDAMED 8d616cb2-3775-4749-94f5-3d0c5e08f6b1 61 fields · synced May 17, 2026
- EUDAMED 272108e8-7b9b-4ff9-add3-f1c1cd62cdb3 61 fields · synced May 17, 2026
- EUDAMED 2a96d704-e6d2-44be-ac9c-862dafabc109 61 fields · synced May 17, 2026
- EUDAMED 5196525f-f49f-4ff1-98b0-ccdaa0663698 61 fields · synced May 17, 2026
- EUDAMED 7715b49d-39a0-45af-a3da-5d7ceea98fae 61 fields · synced May 18, 2026
- EUDAMED 9fda31ae-3fad-4c40-830e-a391f8a5251a 61 fields · synced May 18, 2026
- EUDAMED a7dae3d8-a953-47c3-9e34-883078462c6d 61 fields · synced May 18, 2026
- EUDAMED 25ce79d2-b394-4a16-ae76-0efe91d11386 61 fields · synced May 18, 2026
- EUDAMED 4bbf0b4a-bb22-4080-bd74-62ed09ab4a85 61 fields · synced May 18, 2026
- EUDAMED 9488752b-cb72-4a23-b135-7ec69dcd4bfc 61 fields · synced May 18, 2026
- EUDAMED 041b4651-b5f3-403d-b308-6d609768ae9c 61 fields · synced May 18, 2026
- EUDAMED d9601518-d0c2-4a04-816a-fdf18e41e1be 61 fields · synced May 18, 2026
- EUDAMED f69a10d6-41b5-4d74-84fe-30dc08357912 61 fields · synced May 18, 2026
- EUDAMED 7076d8e6-4559-432f-a26e-e9e9ec61bbdf 61 fields · synced May 18, 2026
- EUDAMED b30c3255-4724-46f2-9028-17d1979569ca 61 fields · synced May 18, 2026
- EUDAMED 0b5ab4fd-08b3-4d39-bdfb-742a933fc467 61 fields · synced May 18, 2026
- EUDAMED b72c1eff-398e-43a7-82bb-a12bf371f645 61 fields · synced May 18, 2026
- EUDAMED 5429d22b-ab98-4d70-9c0b-a284361a8680 61 fields · synced May 18, 2026
- EUDAMED e48b04a0-35f4-4933-81f3-86f1ddff355d 61 fields · synced May 18, 2026
- EUDAMED b05c072d-e5b5-48f9-ac3f-ef9de017774e 61 fields · synced May 18, 2026
- EUDAMED 9352995a-0634-45f9-8ab6-d04fd96a047d 61 fields · synced May 19, 2026
- EUDAMED 714aa486-11e9-4195-9266-aac38a6cc0c0 61 fields · synced May 19, 2026
- EUDAMED 12ed106d-82d4-41d1-8840-1b47b06606d9 61 fields · synced May 19, 2026