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Iontophoresis Electrode, Large 4.0 mL
EUDAMEDFDA UDIClass I (EU MDR)
Ref 199336-001
Identity
- Trade Name
- Iontophoresis Electrode, Large 4.0 mL EUDAMEDDupel BLUE FDA UDI
- Generic Name
- Drug-delivery iontophoresis system electrode, active FDA UDI
- Device Name
- Dupel BLUE EUDAMEDIontophoresis Electrode, Large 4.0 mL FDA UDI
- Model / Reference
- 199336-001 EUDAMEDFDA UDI
- Description
- Iontophoresis Electrode, Large 4.0 mL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850030915108 EUDAMEDFDA UDI
- Basic UDI-DI
- 085003091519933X55 EUDAMED
- FDA Product Code
- EGJ FDA UDI
- EMDN Code
- Z120604 IONTOPHORESIS EQUIPMENT EUDAMED
- GMDN Term
- Drug-delivery iontophoresis system electrode, active FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5525 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Iontophoresis Electrode, Large 4.0 mL by Clearlake-Tech Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 085003091519933X55 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ClearLake-Tech, Inc.
- EUDAMED SRN
- US-MF-000010642
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED ed786b90-bf2f-48c2-a9fe-24546d10d1ca 61 fields · synced Jun 17, 2026
- FDA UDI 5fa94094-1040-47ba-aacb-0a79d1d783bb 33 fields · synced May 22, 2026