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miLab™ Platform
EUDAMEDClass A (EU MDR)
Ref DMLA-AP50, DMLA-AC50, DMLA-SA20Model DMLA
Identity
- Trade Name
- miLab™ Platform EUDAMED
- Device Name
- miLab™ Platform EUDAMED
- Model / Reference
- DMLA EUDAMEDDMLA-AP50, DMLA-AC50, DMLA-SA20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800100100011 EUDAMED
- Basic UDI-DI
- 88001001DE0012P EUDAMED
- EMDN Code
- W0202059002,W0202059099 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
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
miLab™ Platform by Noul Co., 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 | 88001001DE0012P | Class A | Active |
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Manufacturer
- Manufacturer
- Noul Co., Ltd.
- EUDAMED SRN
- KR-MF-000033621
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 530e0868-8bbc-4c00-b4d5-4960867e325a 61 fields · synced Jul 13, 2026
- EUDAMED 530e0868-8bbc-4c00-b4d5-4960867e325a-1 61 fields · synced Jun 10, 2026