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γ-Glutamyl Transferase Assay Kit (Rate Assay)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH020409Model R1: 60 mL×4; R2: 20 mL×4Ref DTSH020403Model R1: 21 mL×1; R2: 7 mL×1Ref DTSH020406Model R1: 30 mL×3; R2: 30 mL×1
Identity
- Device Name
- γ-Glutamyl Transferase Assay Kit (Rate Assay) EUDAMED
- Model / Reference
- R1: 60 mL×4; R2: 20 mL×4 EUDAMEDDTSH020409 EUDAMEDR1: 21 mL×1; R2: 7 mL×1 EUDAMEDDTSH020403 EUDAMEDR1: 30 mL×3; R2: 30 mL×1 EUDAMEDDTSH020406 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225460912 EUDAMED06975225460851 EUDAMED06975225460882 EUDAMED
- Basic UDI-DI
- B-06975225460912 EUDAMEDB-06975225460851 EUDAMEDB-06975225460882 EUDAMED
- EMDN Code
- W01010116 GAMMA GLUTAMYLTRANSFERASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMEDEUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Category: Gamma-glutamyltransferase (GGT) IVD, reagent
γ-Glutamyl Transferase Assay Kit (Rate Assay) by Da Te Bioengineering Technology Co., LTD. — Class IVD General — IVDD — listed in EUDAMED
Similar devices
Also classified as Gamma-glutamyltransferase (GGT) IVD, reagent.
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- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class I
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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-06975225460912 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Da Te Bioengineering Technology Co., LTD.
- EUDAMED SRN
- CN-MF-000028832
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED 5cf6f633-f562-4fdf-ad80-ac24e119dfd7 61 fields · synced Jul 13, 2026
- EUDAMED 58a1d9ee-804b-4ec8-9f35-8437ba6a84e6 61 fields · synced May 18, 2026
- EUDAMED 6c62acd5-abf2-4b2f-9ebf-5144fed3bd05 61 fields · synced May 18, 2026