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Fully automatic library preparation system
EUDAMEDClass A (EU MDR)
Ref iLab-100B
by AMTK Inc.
Identity
- Trade Name
- Fully automatic library preparation system EUDAMED
- Device Name
- Fully automatic library preparation system EUDAMED
- Model / Reference
- iLab-100B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978331210020 EUDAMED
- Basic UDI-DI
- 697833121iLab-100BBH EUDAMED
- Direct Marketing DI
- 06978331210020 EUDAMED
- EMDN Code
- W02060199 ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Fully automatic library preparation system by AMTK 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 | 697833121iLab-100BBH | Class A | Active |
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Manufacturer
- Manufacturer
- AMTK Inc.
- EUDAMED SRN
- CN-MF-000046792
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED 7140dc42-02df-46be-aeaf-5f286141de20 61 fields · synced Jun 19, 2026