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Electrode
EUDAMEDClass A (EU MDR)
Ref DD-62005Ref DD-62004Ref CD-476246Ref DD-62003
Identity
- Trade Name
- Electrode EUDAMED
- Device Name
- Cl- Electrode UNITY EUDAMEDK+ Electode UNITY EUDAMEDpO2 Electrode EUDAMEDNa+ Electrode UNITY EUDAMED
- Model / Reference
- DD-62005 EUDAMEDDD-62004 EUDAMEDCD-476246 EUDAMEDDD-62003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00811403014729 EUDAMED00811403014712 EUDAMED00811403010554 EUDAMED00811403014705 EUDAMED
- Basic UDI-DI
- 081140301DD620058B EUDAMED081140301DD6200489 EUDAMED081140301CD4762469F EUDAMED081140301DD6200387 EUDAMED
- EMDN Code
- W0580 IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Electrode by DIAMOND DIAGNOSTICS Inc — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 081140301DD620058B | Class A | Active |
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Manufacturer
- Manufacturer
- Diamond Diagnostics Inc
- EUDAMED SRN
- US-MF-000035435
- Authorised Representative
- Diamond Diagnostics Inc. Magyarországi Fióktelepe HU-AR-000034351
Sources (4)
- EUDAMED ab82052b-5799-47a7-8848-3e7005777aec 61 fields · synced Aug 1, 2026
- EUDAMED 108f8200-a111-476a-8997-42305c3fb21a 61 fields · synced May 17, 2026
- EUDAMED 51eaa3dd-786b-4d95-937d-a66835733f47 61 fields · synced May 17, 2026
- EUDAMED 60c8fba2-002a-40b4-a6eb-d9d55ce38696 61 fields · synced May 18, 2026