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AQUAmed
EUDAMEDClass I (EU MDR)
Ref AQUA-EKG01
by Aqua Medi̇kal Tibbi̇ Araç Ve Gereç İnş. San. Diş Ti̇c. Ltd. Şti̇.
Identity
- Trade Name
- AQUAmed EUDAMED
- Device Name
- AQUAmed ECG ELECTRODE ADULT EUDAMED
- Model / Reference
- AQUA-EKG01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680525625319 EUDAMED
- Basic UDI-DI
- 868052562EKGELKHX EUDAMED
- Direct Marketing DI
- 08680525625319 EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES 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
Category: Electrocardiographic electrode, single-use
AQUAmed by Aqua Medi̇kal Tibbi̇ Araç Ve Gereç İnş. San. Diş Ti̇c. Ltd. Şti̇. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic electrode, single-use.
- ECG leadwire — Shenzhen City Teveik Technology Co., Ltd. · Class I
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- SWAROMED — TYROLMED GmbH · Class II
- SWAROMED — TYROLMED GmbH · Class II
- SWAROMED — TYROLMED GmbH · Class II
- PG10S /RU26 — FIAB S.p.A. · Class I
- 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 | 868052562EKGELKHX | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- TR-MF-000023642
Sources (1)
- EUDAMED d7d118af-211f-4eee-aa5d-af6931afd39c 61 fields · synced Jun 19, 2026