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On Call Plus Blood Glucose Test Strips
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref G133-111Model OGS-541Ref G133-119Ref G133-117Ref G133-114Ref G133-211
Identity
- Trade Name
- On Call Plus Blood Glucose Test Strips EUDAMED
- Device Name
- On Call Plus Blood Glucose Test Strips EUDAMED
- Model / Reference
- OGS-541 EUDAMEDG133-111 EUDAMEDG133-119 EUDAMEDG133-117 EUDAMEDG133-114 EUDAMEDG133-211 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-G133-111GW EUDAMEDD-G133-119HE EUDAMEDD-G133-117HA EUDAMEDD-G133-114H4 EUDAMEDD-G133-211H3 EUDAMED
- Basic UDI-DI
- B-G133-111GW EUDAMEDB-G133-119HE EUDAMEDB-G133-117HA EUDAMEDB-G133-114H4 EUDAMEDB-G133-211H3 EUDAMED
- EMDN Code
- W0101060101 GLUCOSE TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
On Call Plus Blood Glucose Test Strips by Acon Biotech (Hangzhou) Co., Ltd. — Class IVD Annex II List B — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-G133-111GW | Class IVD Annex II List B | 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 (5)
- EUDAMED 2e561054-2987-4e56-9c22-e13ace99de3f 61 fields · synced Oct 6, 2026
- EUDAMED 2d5ac3cf-4fd3-4a53-90ef-25aeb41c4ce7 61 fields · synced May 17, 2026
- EUDAMED ecedd130-8e07-4065-9b83-806994d32c18 61 fields · synced May 18, 2026
- EUDAMED bf09b062-6348-41d0-b38b-c6a76adf202a 61 fields · synced May 18, 2026
- EUDAMED 6c4c3935-1d5b-4269-a13c-0e0018ae3f65 61 fields · synced May 19, 2026