Identity
- Trade Name
- GT NUCLEIC ACID PREP KIT EUDAMED
- Device Name
- GT NUCLEIC ACID PREP KIT EUDAMED
- Model / Reference
- GT-PREP-1 EUDAMEDGT-PREP-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18800076500461 EUDAMED18800076500508 EUDAMED
- Basic UDI-DI
- 88000765PREP1PX EUDAMED
- EMDN Code
- W02050106 DNA GENOMIC PREPARATION DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
New Device
Yes
EUDAMED
Gt Nucleic Acid Prep Kit by Genomictree, Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 88000765PREP1PX | Class A | Active |
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Manufacturer
- Manufacturer
- Genomictree, Inc.
- EUDAMED SRN
- KR-MF-000037890
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (2)
- EUDAMED 4b4190b6-3fc7-48ae-8d86-63360cd658b5 61 fields · synced Jul 9, 2026
- EUDAMED be19e7f6-406c-4296-aee4-ec3bedbc2758 61 fields · synced May 18, 2026