← Back to catalogue
Fully automatic library preparation system
EUDAMEDClass A (EU MDR)
Ref iLab-100ARef iLab-200Ref iLab-300Ref iLab-100
by AMTK Inc.
Identity
- Trade Name
- Fully automatic library preparation system EUDAMED
- Device Name
- Fully automatic library preparation system EUDAMED
- Model / Reference
- iLab-100A EUDAMEDiLab-200 EUDAMEDiLab-300 EUDAMEDiLab-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978331210013 EUDAMED06978331210037 EUDAMED06978331210044 EUDAMED06978331210006 EUDAMED
- Basic UDI-DI
- 697833121iLab-100ABF EUDAMED697833121iLab-200UB EUDAMED697833121iLab-300UG EUDAMED697833121iLab-100U6 EUDAMED
- Direct Marketing DI
- 06978331210013 EUDAMED06978331210037 EUDAMED06978331210044 EUDAMED06978331210006 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-100ABF | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- AMTK Inc.
- EUDAMED SRN
- CN-MF-000046792
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (4)
- EUDAMED cf681c44-f889-479c-a1ea-d2f464e9d6c4 61 fields · synced Jul 20, 2026
- EUDAMED d546015e-7d01-45ed-ad79-364f121b9535 61 fields · synced May 16, 2026
- EUDAMED 127c5bed-5c7b-4da0-8c74-d43bdb893166 61 fields · synced May 18, 2026
- EUDAMED 124d6205-00fd-470b-8b8c-d022346dcb1a 61 fields · synced May 19, 2026