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Aerospray® TB Reagent B, Potassium Permanganate
EUDAMEDClass A (EU MDR)
Ref SS-061BP-EUModel Aerospray Stains Ref SS-161BP
Identity
- Trade Name
- Aerospray® TB Reagent B, Potassium Permanganate EUDAMEDAerospray® TB Reagent B, Potassium Permanganate Concentrate EUDAMED
- Model / Reference
- Aerospray Stains EUDAMEDSS-061BP-EU EUDAMEDSS-161BP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03661540303494 EUDAMED03661540303036 EUDAMED
- Basic UDI-DI
- 3661540Aerospray-StainXL EUDAMED
- Direct Marketing DI
- 03661540303494 EUDAMED03661540303036 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® TB Reagent B, Potassium Permanganate 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 (2)
- EUDAMED 5c4aff20-289b-4ac9-bebf-76c871d34152 61 fields · synced Jul 19, 2026
- EUDAMED 9ece2f3c-f5f1-428f-a37d-8a1266e23fda 61 fields · synced May 18, 2026