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Biosoft Tissue Softening Agent
EUDAMEDClass A (EU MDR)
Ref RRDC7-EModel Decalcifying Solution
Identity
- Trade Name
- Biosoft Tissue Softening Agent EUDAMED
- Model / Reference
- Decalcifying Solution EUDAMEDRRDC7-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060405295697 EUDAMED
- Basic UDI-DI
- 505591470RRDCE7 EUDAMED
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Northern Ireland 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
Biosoft Tissue Softening Agent by Atom Scientific Ltd — 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 | 505591470RRDCE7 | Class A | Active |
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Manufacturer
- Manufacturer
- Atom Scientific Ltd
- EUDAMED SRN
- UK-MF-000046578
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 163debb4-88ef-45eb-9b20-9c24b36608a3 61 fields · synced Jul 28, 2026