← Back to catalogue
Katsura Biological Coporation
EUDAMEDClass A (EU MDR)
Ref S2R16BRef 310111Ref 310211Ref 310311Ref 320311
Identity
- Trade Name
- Katsura Biological Coporation EUDAMED
- Device Name
- S2R16B Fully Integrated Diagnostics Platform EUDAMEDViral DNA/RNA Respi Kit EUDAMEDViral DNA/RNA Universal Kit EUDAMEDWhole Blood DNA Kit EUDAMEDGenomic DNA Kit EUDAMED
- Model / Reference
- S2R16B EUDAMED310111 EUDAMED310211 EUDAMED310311 EUDAMED320311 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719883180018 EUDAMED04719883180025 EUDAMED04719883180056 EUDAMED04719883180063 EUDAMED04719883180032 EUDAMED
- Basic UDI-DI
- 471988318S2R16BGB EUDAMED471988318310111SL EUDAMED471988318310211SR EUDAMED471988318310311SW EUDAMED471988318320311T9 EUDAMED
- Direct Marketing DI
- 04719883180018 EUDAMED04719883180056 EUDAMED04719883180063 EUDAMED04719883180032 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMEDW0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMEDEUDAMED
New Device
No
EUDAMED
Category: Nucleic acid sample preparation instrument IVD
Katsura Biological Coporation by Katsura Biological Corp — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Nucleic acid sample preparation instrument IVD.
- Applied Biosystems™ SeqStudio™ 24 Flex Dx Genetic Analyzer — Life Technologies Holdings Pte Ltd. · Class A
- TANBead Nucleic Acid Extractor — Taiwan Advanced Nanotech Inc. · Class A
- NC-15Plus(32) — HANWOOLTPC Co., Ltd. · Class A
- 3500 Dx Genetic Analyzer — Life Technologies Holdings Pte Ltd. · Class A
- ALLSHENG — HANGZHOU ALLSHENG INSTRUMENTS CO., LTD. · Class I
- isoQuarkM4 — RevoSketch Inc. · Class A
- Automated Nucleic Acid Extraction and Amplification System — Hybribio Medtech Device Co.,Ltd · Class A
- Real-time PCR system — Hangzhou Bio-gener Technology Co., 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 | 471988318S2R16BGB | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Katsura Biological Corp
- EUDAMED SRN
- TW-MF-000044228
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (5)
- EUDAMED 2cd588eb-324c-402d-b367-ab36099feaca 61 fields · synced Sep 18, 2026
- EUDAMED 903c2eaf-ee19-4540-a1ee-0988ecbb79ba 61 fields · synced May 17, 2026
- EUDAMED 9ecc86e3-0e79-43b1-b44e-4efe4f492922 61 fields · synced May 17, 2026
- EUDAMED e1aca414-3e98-4f7d-b64d-09a9a5a00ab5 61 fields · synced May 17, 2026
- EUDAMED e6257b95-328a-43df-bac7-4f9a874be5fc 61 fields · synced May 19, 2026