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Rossmax
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref BGM_KIT_004_RMModel Rossmax HS200Ref BGM_TS_007_RMModel Rossmax HS200Ref BGM_KIT_002_RMRef T05H1690050SN
Identity
- Trade Name
- Rossmax EUDAMED
- Device Name
- Rossmax HS200 Blood Glucose Monitoring System EUDAMEDRossmax HS200 Blood Glucose Test Strips EUDAMEDRossmax HS200 Control Solution EUDAMED
- Model / Reference
- Rossmax HS200 EUDAMEDBGM_KIT_004_RM EUDAMEDBGM_TS_007_RM EUDAMEDBGM_KIT_002_RM EUDAMEDT05H1690050SN EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-T05H1690070KNQK EUDAMEDD-T05H1690077ANQQ EUDAMEDD-T05H1690071KNQQ EUDAMEDD-T05H1690050SNQV EUDAMEDD-T05H1690040KNPW EUDAMED
- Basic UDI-DI
- B-T05H1690070KNQK EUDAMEDB-T05H1690077ANQQ EUDAMEDB-T05H1690071KNQQ EUDAMEDB-T05H1690050SNQV EUDAMEDB-T05H1690040KNPW EUDAMED
- EMDN Code
- W0201060102 BLOOD GLUCOSE METERS EUDAMEDW0101060101 GLUCOSE TEST STRIPS EUDAMEDW010106010801 BLOOD TEST STRIPS CONTROLS EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMEDClass IVD Annex II List B EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMEDEUDAMED
Rossmax by Tyson Bioresearch, Inc. — Class IVD devices for self-testing — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-T05H1690070KNQK | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Tyson Bioresearch, Inc.
- EUDAMED SRN
- TW-MF-000027508
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (5)
- EUDAMED c8ae7965-6688-4e44-a7f3-9459ca520f99 61 fields · synced Jul 29, 2026
- EUDAMED fbc7ade4-8f6f-4fd3-b023-39dd51112b5c 61 fields · synced May 17, 2026
- EUDAMED ddbbed6f-c959-44ed-af67-09489a30f4bb 61 fields · synced May 17, 2026
- EUDAMED f01fd5d3-2d61-498e-862b-71c2097a3119 61 fields · synced May 18, 2026
- EUDAMED e8f643dd-bbb8-49a4-9faa-ac86d1af8349 61 fields · synced May 18, 2026