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Aerospray Gram Reagent A, Decolorizer with Acetone and Safranine
EUDAMEDClass A (EU MDR)
Ref SS-041AAModel Aerospray Stains
Identity
- Trade Name
- Aerospray Gram Reagent A, Decolorizer with Acetone and Safranine EUDAMED
- Model / Reference
- Aerospray Stains EUDAMEDSS-041AA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03661540302282 EUDAMED
- Basic UDI-DI
- 3661540Aerospray-StainXL EUDAMED
- Direct Marketing DI
- 03661540302282 EUDAMED
- EMDN Code
- W0104010804 STAINS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Aerospray Gram Reagent A, Decolorizer with Acetone and Safranine by Elitechgroup 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 | 3661540Aerospray-StainXL | Class A | Active |
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Manufacturer
- Manufacturer
- ELITechGroup Inc.
- EUDAMED SRN
- US-MF-000006942
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 5b8f862a-ec2b-41d8-8a07-a639a1064275 61 fields · synced Jul 13, 2026