Identity
- Trade Name
- FE Laminar Liquid EUDAMED
- Device Name
- Chemistry Reagent EUDAMED
- Model / Reference
- 1036253 EUDAMED3020185 EUDAMED3019900 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794513427 EUDAMED06925794580719 EUDAMED06925794577597 EUDAMED
- Basic UDI-DI
- 69257945W01019099R04Y EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
FE Laminar Liquid by Dirui Industrial Co., Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69257945W01019099R04Y | Class A | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED e59b718e-9022-44d5-acba-41fd7a04d28d 61 fields · synced Jul 11, 2026
- EUDAMED 0e4dff75-6e5f-4025-ba24-0e1eb195dc9a 61 fields · synced Jul 9, 2026
- EUDAMED e6384574-be9e-4bdf-a118-578b1761da36 61 fields · synced Jul 11, 2026