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Proneo
EUDAMEDClass I (EU MDR)
Ref SR15 (WBR)Model SG15LRef SG15 (RBG)Ref SR15LRef SR15Ref SR20SRef SR15 (RGY)Ref SG15 (WBG)Ref SG20SRef SR15 (WBG)
Identity
- Trade Name
- PRONEO EUDAMED
- Device Name
- Neonatal ECG Electrode EUDAMED
- Model / Reference
- SG15L EUDAMEDSR15 (WBR) EUDAMEDSG15 (RBG) EUDAMEDSR15L EUDAMEDSR15 EUDAMEDSR20S EUDAMEDSR15 (RGY) EUDAMEDSG15 (WBG) EUDAMEDSG20S EUDAMEDSR15 (WBG) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809083947842 EUDAMED08809083947804 EUDAMED08809083948528 EUDAMED08809083947811 EUDAMED08809083948542 EUDAMED08809083947828 EUDAMED08809083947798 EUDAMED08809083948535 EUDAMED08809083947835 EUDAMED
- Basic UDI-DI
- 880908394020KF EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Proneo by Bio Protech Inc. — 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 | 880908394020KF | Class I | Active |
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Manufacturer
- Manufacturer
- Bio Protech Inc.
- EUDAMED SRN
- KR-MF-000012687
- Authorised Representative
- Meridius Medical Europe Limited IE-AR-000004258
Sources (9)
- EUDAMED 1852fd81-db0e-4365-a478-4d2083a1bd93 61 fields · synced Sep 17, 2026
- EUDAMED 0ecdff30-8781-4219-8078-a430b99474c7 61 fields · synced May 17, 2026
- EUDAMED 629fed79-3f99-42f9-9f97-98e2fbd2f18f 61 fields · synced May 17, 2026
- EUDAMED 1692ebe7-780d-4166-b65f-fb489d6467d1 61 fields · synced May 17, 2026
- EUDAMED bbdfd3eb-04ca-4fec-862c-f63c977fb476 61 fields · synced May 17, 2026
- EUDAMED 47344c20-5a55-4685-90b6-e029d00cd4f4 61 fields · synced May 18, 2026
- EUDAMED deecb514-da89-4979-b399-eb5305e966f9 61 fields · synced May 18, 2026
- EUDAMED f864999d-ab0f-4774-85ca-8cf9a62f4ea3 61 fields · synced May 18, 2026
- EUDAMED c938840e-908f-4c4c-b05a-877eb6f62229 61 fields · synced May 18, 2026