Identity
- Trade Name
- DML 3000 EUDAMEDFDA UDI
- Generic Name
- Photometer, absorbance/transmission, automated FDA UDI
- Device Name
- digene Microplate Luminometer 3000 (DML 3000) EUDAMED
- Model / Reference
- 5000-00031 EUDAMED1 FDA UDI
Identifiers
- Catalog Number
- 5000-00031 FDA UDI
- Primary DI / UDI-DI
- 04053228010777 EUDAMEDFDA UDI
- Basic UDI-DI
- 4053228IHC2DML0000000017V EUDAMED
- Direct Marketing DI
- 04053228010777 EUDAMED
- PMA Number
- P890064 FDA UDI
- FDA Product Code
- MAQ FDA UDI
- EMDN Code
- W02050199 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER EUDAMED
- GMDN Term
- Photometer, absorbance/transmission, automated FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass III FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dml 3000 by QIAGEN Sciences LLC — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 4053228IHC2DML0000000017V | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- QIAGEN Sciences LLC
- EUDAMED SRN
- US-MF-000014502
- Authorised Representative
- QIAGEN GmbH DE-AR-000004971
Sources (2)
- EUDAMED 4be5aa64-6655-47ff-a0c1-5970346565f7 61 fields · synced Jul 26, 2026
- FDA UDI a000f98a-0870-4c17-8dd1-5377352d3db5 34 fields · synced May 29, 2026