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SDSB Medical Solutions
EUDAMEDClass I (EU MDR)
Ref ES GS 30Ref ES GS 4256Ref ES GM 3648Ref ES GS 3648Ref ES GM 30Ref ES GM 4256Ref ES GS 50
Identity
- Trade Name
- SDSB Medical Solutions EUDAMED
- Device Name
- ECG Electrode EUDAMED
- Model / Reference
- ES GS 30 EUDAMEDES GS 4256 EUDAMEDES GM 3648 EUDAMEDES GS 3648 EUDAMEDES GM 30 EUDAMEDES GM 4256 EUDAMEDES GS 50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05905858930149 EUDAMED05905858930132 EUDAMED05905858930194 EUDAMED05905858930125 EUDAMED05905858930170 EUDAMED05905858930200 EUDAMED05905858930156 EUDAMED
- Basic UDI-DI
- 5903246098ECGELECTRODEXB EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Category: Electrocardiographic electrode, single-use
SDSB Medical Solutions by Esvico Sp. z o.o. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Electrocardiographic electrode, single-use.
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- Medline — MEDLINE INDUSTRIES, INC. · Class II
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 | 5903246098ECGELECTRODEXB | Class I | Active |
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Manufacturer
- Manufacturer
- Esvico Sp. z o.o.
- EUDAMED SRN
- PL-MF-000022702
Sources (7)
- EUDAMED a608ddc0-d38d-43c9-bbc4-795d8f6e1e18 61 fields · synced Jul 31, 2026
- EUDAMED 5cdfad9a-b593-4105-97da-fcf954998349 61 fields · synced May 16, 2026
- EUDAMED 4d068d13-2b66-4094-a12f-8fae7d9db0e1 61 fields · synced May 16, 2026
- EUDAMED 06c7ab3f-7f61-48e9-9904-71b541894d5d 61 fields · synced May 17, 2026
- EUDAMED e93fd850-0ad0-46e1-9642-440cf716306e 61 fields · synced May 17, 2026
- EUDAMED 02bd0c15-e60b-451e-8bd0-d25cd47cfcb3 61 fields · synced May 17, 2026
- EUDAMED 4e8fa299-d887-4bf3-9f7b-bcde559639fa 61 fields · synced May 18, 2026