Identity
- Trade Name
- QIAsymphony SP EUDAMEDFDA UDI
- Generic Name
- Nucleic acid sample preparation instrument IVD FDA UDI
- Device Name
- QIAsymphony SP EUDAMED
- Model / Reference
- 9001297 EUDAMED1 FDA UDI
Identifiers
- Catalog Number
- 9001297 FDA UDI
- Primary DI / UDI-DI
- 04053228010739 EUDAMEDFDA UDI
- Basic UDI-DI
- 4053228IQSSP00000000001DY EUDAMED
- Direct Marketing DI
- 04053228010739 EUDAMED
- FDA Product Code
- JJH FDA UDI
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
- GMDN Term
- Nucleic acid sample preparation instrument IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2310 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nucleic acid sample preparation instrument IVD
QIAsymphony SP by QIAGEN GmbH — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — 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 (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 4053228IQSSP00000000001DY | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- QIAGEN GmbH
- EUDAMED SRN
- DE-MF-000004949
Sources (2)
- EUDAMED 4f5deade-06c5-4351-b8de-02520eab42cb 61 fields · synced Jun 18, 2026
- FDA UDI 7535eb69-a909-4c02-8da7-a6dbb09d3b44 33 fields · synced May 30, 2026