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DELBIO GS2 Nucleic Acid Extraction Kit
EUDAMEDClass A (EU MDR)
Ref DBDIIB004E00(GB-004)
by Delbio Inc.
Identity
- Trade Name
- DELBIO GS2 Nucleic Acid Extraction Kit EUDAMED
- Device Name
- Nucleic Acid Extraction Kit EUDAMED
- Model / Reference
- DBDIIB004E00(GB-004) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04713072985101 EUDAMED
- Basic UDI-DI
- 471307298GB1FA EUDAMED
- Direct Marketing DI
- 04713072985101 EUDAMED
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
No
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
DELBIO GS2 Nucleic Acid Extraction Kit by Delbio Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Nucleic acid extraction/isolation kit IVD.
- Whole Blood DNA Extraction Kit (Magnetic Bead Method) — JIANGSU BIOPERFECTUS TECHNOLOGIES CO., LTD. · Class A
- abGenix™ Viral DNA and RNA Extraction Kit II (Plate) — AITbiotech Pte Ltd · Class A
- Nucleic Acid Extraction Kit — Shandong Bohong Gene Technology Co., Ltd. · Class A
- HPLC column — Immundiagnostik AG · Class A
- VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
- ViraSens Total Nucleic Acid Purification Kit — Vitrosens Biotechnology Inc. · Class A
- Nucleic Acid Extraction Kit — Bioteke Corporation (Wuxi) Co., Ltd. · Class A
- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
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 | 471307298GB1FA | Class A | Active |
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Manufacturer
- Manufacturer
- Delbio Inc.
- EUDAMED SRN
- TW-MF-000003400
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED edf1d326-93e3-4e74-8bdc-e2cfc76e702d 61 fields · synced Jun 18, 2026