Identity
- Trade Name
- Consumable EUDAMED
- Device Name
- Consumable EUDAMED
- Model / Reference
- HCLIA1101A,HCLIA1101B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974524062315 EUDAMED
- Basic UDI-DI
- 697452406UZ4E EUDAMED
- Direct Marketing DI
- 06974524062315 EUDAMED
- EMDN Code
- W0201069085 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
New Device
No
EUDAMED
Consumable by Nanjing Poclight Biotechnology 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 | 697452406UZ4E | Class A | Active |
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Manufacturer
- Manufacturer
- Nanjing Poclight Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000039609
- Authorised Representative
- HUMISS TRADING S. L. ES-AR-000040177
Sources (2)
- EUDAMED c300635f-bcc4-4e49-b4d0-8f49906005ba 61 fields · synced Jun 18, 2026
- EUDAMED c300635f-bcc4-4e49-b4d0-8f49906005ba-1 61 fields · synced Jun 10, 2026