Identity
- Trade Name
- EA/Orange-G Combo Stain EUDAMED
- Device Name
- EA/Orange-G Combo Stain EUDAMED
- Model / Reference
- C0051MN28 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973094411387 EUDAMED
- Basic UDI-DI
- B-06973094411387 EUDAMED697309441EOStainGU EUDAMED
- EMDN Code
- W0103010301 HISTO / CYTO STAINS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass A EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
EA/Orange-G Combo Stain by Junocare Medical Devices Ltd — Class I — IVDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06973094411387 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06973094411387 | Class I | Active |
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Manufacturer
- Manufacturer
- Junocare Medical Devices Ltd
- EUDAMED SRN
- CN-MF-000030653
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (2)
- EUDAMED 1f09070d-d239-4c9d-a320-551773de4b82 61 fields · synced Jun 18, 2026
- EUDAMED 10ce84bc-8c02-4020-93f7-a83691117ef2 61 fields · synced Jun 18, 2026