Identity
- Trade Name
- ROMO CHECK PLUS Lancets EUDAMED
- Device Name
- ROMO CHECK PLUS Lancets EUDAMED
- Model / Reference
- GS-9008-10L EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GS-9008-10LWK EUDAMED
- Basic UDI-DI
- B-GS-9008-10LWK EUDAMED
- EMDN Code
- V010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ROMO CHECK PLUS Lancets by Acon Biotech (Hangzhou) Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-GS-9008-10LWK | Class IIa | Active |
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Manufacturer
- Manufacturer
- Acon Biotech (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000006977
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 324805e5-2f25-44fc-9674-d3623f3ffb09 61 fields · synced Jun 18, 2026