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Γ-Glutamyl Transferase Reagent Kit（ifcc Method）
EUDAMEDClass IVD General (EU MDR)
Ref 3000442Model R1: 4x80mL, R2: 4x20mLRef 3023250Model R1: 4x50mL, R2: 2x25mLRef 3016520Model R1: 4x50mL, R2: 1x50mLRef 3000444Model R1: 2x60mL, R2: 2x15mLRef 3019415Model R1: 2L, R2: 500mLRef 3021635Ref 3016541
Identity
- Trade Name
- γ-GLUTAMYL TRANSFERASE REAGENT KIT（IFCC METHOD） EUDAMED
- Device Name
- γ-GLUTAMYL TRANSFERASE REAGENT KIT（IFCC METHOD） EUDAMED
- Model / Reference
- R1: 4x80mL, R2: 4x20mL EUDAMED3000442 EUDAMEDR1: 4x50mL, R2: 2x25mL EUDAMED3023250 EUDAMEDR1: 4x50mL, R2: 1x50mL EUDAMED3016520 EUDAMEDR1: 2x60mL, R2: 2x15mL EUDAMED3000444 EUDAMEDR1: 2L, R2: 500mL EUDAMED3019415 EUDAMED3021635 EUDAMED3016541 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202258732 EUDAMED06942202213083 EUDAMED06942202258718 EUDAMED06942202258701 EUDAMED06925794581181 EUDAMED06925794592125 EUDAMED06942202258725 EUDAMED
- Basic UDI-DI
- B-06942202258732 EUDAMEDB-06942202213083 EUDAMEDB-06942202258718 EUDAMEDB-06942202258701 EUDAMEDB-06925794581181 EUDAMEDB-06925794592125 EUDAMEDB-06942202258725 EUDAMED
- EMDN Code
- W01010199 ENZYMES - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Γ-Glutamyl Transferase Reagent Kit（ifcc Method） by Dirui Industrial Co., Ltd — Class IVD General — 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-06942202258732 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (7)
- EUDAMED 6edadb22-8f6d-4742-8bb7-ed3cb30c3ae2 61 fields · synced Sep 17, 2026
- EUDAMED fe3572a8-6efe-4f59-88af-0878030694b3 61 fields · synced May 18, 2026
- EUDAMED b7a791ae-e487-4221-811d-7cd5fc0fed83 61 fields · synced May 18, 2026
- EUDAMED 670cd988-9c7c-4ba1-bb22-8e3696f835bd 61 fields · synced May 18, 2026
- EUDAMED 73d43db9-c7db-429e-a820-954139551e04 61 fields · synced May 18, 2026
- EUDAMED 118afea4-ffc7-4393-a490-bffc0278b8a5 61 fields · synced May 18, 2026
- EUDAMED bf9c33a5-9adf-47c4-8a6b-171406f6e675 61 fields · synced May 19, 2026