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Aerospray® TB Reagent B, Methylene Blue
EUDAMEDClass A (EU MDR)
Ref SS-161BMB Model Aerospray Stains Ref SS-061BMB
Identity
- Trade Name
- Aerospray® TB Reagent B, Methylene Blue EUDAMEDAerospray TB Reagent B, Methylene Blue EUDAMED
- Model / Reference
- Aerospray Stains EUDAMEDSS-161BMB EUDAMEDSS-061BMB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03661540303029 EUDAMED03661540302480 EUDAMED
- Basic UDI-DI
- 3661540Aerospray-StainXL EUDAMED
- Direct Marketing DI
- 03661540303029 EUDAMED03661540302480 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, Methylene Blue 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 0f8b827b-3a2b-4113-9d8d-0c3a2f406928 61 fields · synced Aug 1, 2026
- EUDAMED ca295d06-42d4-4568-9dc1-29d048b20153 61 fields · synced May 18, 2026