Identity
- Trade Name
- Iodine EUDAMED
- Device Name
- Gram Reagents EUDAMED
- Model / Reference
- RWG0112B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033928530658 EUDAMED
- Basic UDI-DI
- 803392853GRAMF6 EUDAMED
- EMDN Code
- W0104010804 STAINS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Iodine by Delcon Srl — 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 | 803392853GRAMF6 | Class A | Active |
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Manufacturer
- Manufacturer
- Delcon Srl
- EUDAMED SRN
- IT-MF-000014234
Sources (1)
- EUDAMED 7d8160b5-c533-4e56-9409-1c45982e385d 61 fields · synced Jul 9, 2026