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Iontophoresis Electrode, Small 1.5 mL, Packet
EUDAMEDClass I (EU MDR)
Ref 199332-001
Identity
- Trade Name
- Iontophoresis Electrode, Small 1.5 mL, Packet EUDAMED
- Device Name
- Dupel BLUE EUDAMED
- Model / Reference
- 199332-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850030915139 EUDAMED
- Basic UDI-DI
- 085003091519933X55 EUDAMED
- EMDN Code
- Z120604 IONTOPHORESIS EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Iontophoresis Electrode, Small 1.5 mL, Packet by Clearlake-Tech 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 | 085003091519933X55 | Class I | Active |
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Manufacturer
- Manufacturer
- ClearLake-Tech, Inc.
- EUDAMED SRN
- US-MF-000010642
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 2dbeabd7-4deb-4ed7-86ed-4779492c7896 61 fields · synced Jun 19, 2026