Identity
- Trade Name
- ABility Smart Extract EUDAMED
- Device Name
- ABility Smart Extract EUDAMED
- Model / Reference
- AB0030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760322820133 EUDAMED03760322820126 EUDAMED
- Basic UDI-DI
- 376032282APAN2234K EUDAMED
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
Category: Nucleic acid extraction/isolation kit IVD
ABility Smart Extract by Appolon Bioteck — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
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 | 376032282APAN2234K | Class A | Active |
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Manufacturer
- Manufacturer
- Appolon Bioteck
- EUDAMED SRN
- FR-MF-000022234
Sources (2)
- EUDAMED a554276f-f57e-4afd-bbe6-d05d2912c0f1 61 fields · synced Jul 9, 2026
- EUDAMED cc43930d-b8c0-441a-a905-f1526cfb8b04 61 fields · synced May 16, 2026