Identity
- Trade Name
- EA/Orange-G Combo Stain EUDAMED
- Device Name
- EA/Orange-G Combo Stain EUDAMED
- Model / Reference
- 90-1560-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973094411257 EUDAMED
- Basic UDI-DI
- B-06973094411257 EUDAMED697309441EOStainGU EUDAMED
- EMDN Code
- W0103010301 HISTO / CYTO STAINS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass A EUDAMED
- Market of Registration
- Germany 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-06973094411257 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06973094411257 | 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 f11785b3-82ff-43dc-892f-dc6070534c0a 61 fields · synced Jul 10, 2026
- EUDAMED 9f148ff2-b9f3-4e77-b0af-9aa24308cd0b 61 fields · synced Jul 10, 2026