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Defibrillation Electrodes
EUDAMEDClass I (EU MDR)
Ref OBS-DE/MP/aModel OBS-DE/PRef OBS-DE/ME/aRef OBS-DE/WRef OBS-DE/SC2/aRef OBS-DE/P3/aRef OBS-DE/CU1/aRef OBS-DE/NK1/aRef OBS-DE/P2/aRef OBS-DE/Z1 Ref OBS-DE/Z2Ref OBS-DE/MRef OBS-DE/CU2/aRef OBS-DE/NK2/a
Identity
- Trade Name
- Defibrillation Electrodes EUDAMED
- Device Name
- Defibrillation Electrodes EUDAMED
- Model / Reference
- OBS-DE/P EUDAMEDOBS-DE/MP/a EUDAMEDOBS-DE/ME/a EUDAMEDOBS-DE/W EUDAMEDOBS-DE/SC2/a EUDAMEDOBS-DE/P3/a EUDAMEDOBS-DE/CU1/a EUDAMEDOBS-DE/NK1/a EUDAMEDOBS-DE/P2/a EUDAMEDOBS-DE/Z1 EUDAMEDOBS-DE/Z2 EUDAMEDOBS-DE/M EUDAMEDOBS-DE/CU2/a EUDAMEDOBS-DE/NK2/a EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939411509892 EUDAMED06939411510980 EUDAMED06939411509717 EUDAMED06939411509953 EUDAMED06939411509625 EUDAMED06939411509830 EUDAMED06939411509809 EUDAMED06939411509571 EUDAMED06939411509595 EUDAMED06939411506105 EUDAMED06939411509779 EUDAMED06939411509687 EUDAMED06939411509861 EUDAMED06939411511017 EUDAMED
- Basic UDI-DI
- 69394115OBS-DEQ3 EUDAMED
- Direct Marketing DI
- 06939411509717 EUDAMED06939411506105 EUDAMED06939411509687 EUDAMED
- EMDN Code
- C020401 EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Defibrillation Electrodes by Baisheng Medical Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69394115OBS-DEQ3 | Class I | Active |
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Manufacturer
- Manufacturer
- Baisheng Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000024558
- Authorised Representative
- Gardien Limited IE-AR-000034828
Sources (14)
- EUDAMED d2642a54-b09c-4de2-be57-b2af814a4226 61 fields · synced Oct 6, 2026
- EUDAMED fde57b59-0ecd-493f-9afa-0b5e59e6baa1 61 fields · synced May 11, 2026
- EUDAMED 47eb8415-375f-4581-b884-192736188e58 61 fields · synced May 16, 2026
- EUDAMED 0b2a4071-8238-4b03-99f2-5cce52899caa 61 fields · synced May 16, 2026
- EUDAMED 479faba8-621a-4d7f-9072-baacab28124b 61 fields · synced May 16, 2026
- EUDAMED 7dfd319a-538a-403b-b884-6baea8bbdd8a 61 fields · synced May 16, 2026
- EUDAMED ec5a0616-af5d-46bc-a8fb-7fa664393837 61 fields · synced May 16, 2026
- EUDAMED 07b1d501-6c71-4c2b-a9fb-ee1a79c2a9cd 61 fields · synced May 17, 2026
- EUDAMED 52eafcba-e92c-49b8-b9f9-54eed5499ba3 61 fields · synced May 17, 2026
- EUDAMED 653a061c-900a-462e-a319-0213b5031a4f 61 fields · synced May 17, 2026
- EUDAMED 54043fc4-848c-4172-b693-b9a2b4b47d66 61 fields · synced May 17, 2026
- EUDAMED 62441a17-8055-4bf8-b4d5-d36b26738b4d 61 fields · synced May 18, 2026
- EUDAMED 366732f7-aa8d-4644-8401-cfc0dd2b74f0 61 fields · synced May 18, 2026
- EUDAMED 1a51b0ab-2f0b-40b8-b095-c0b953aa85e4 61 fields · synced May 19, 2026