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Polymer Delivery Pump Cleaning Kit Dx
EUDAMEDFDA UDIClass A (EU MDR)
Ref 4461875
Identity
- Trade Name
- Polymer Delivery Pump Cleaning Kit Dx EUDAMEDPump cleaning Kit (3500Dx series) FDA UDI
- Generic Name
- Medical device cleaning agent FDA UDI
- Device Name
- Polymer Delivery Pump Cleaning Kit Dx, a part of Genetic Analyzer Reagents and Consumables EUDAMEDKIT,PDP CLEANING 3500 IVD FDA UDI
- Model / Reference
- 4461875 EUDAMEDFDA UDI
- Description
- KIT,PDP CLEANING 3500 IVD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190302000666 EUDAMEDFDA UDI
- Basic UDI-DI
- 0190302TCF00005034A EUDAMED
- FDA Product Code
- PCA FDA UDI
- EMDN Code
- W02050185 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES EUDAMED
- GMDN Term
- Medical device cleaning agent FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.2570 FDA UDI
- Market of Registration
- Netherlands 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
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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Polymer Delivery Pump Cleaning Kit Dx by Life Technologies Holdings Pte Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 0190302TCF00005034A | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Life Technologies Holdings Pte Ltd
- EUDAMED SRN
- SG-MF-000023931
- Authorised Representative
- Life Technologies Europe B.V. NL-AR-000021890
Sources (2)
- EUDAMED 4b1a0c03-23de-4ce8-8834-b5b29a339ca6 61 fields · synced Jul 8, 2026
- FDA UDI c419bd7a-7b54-4573-a4e4-61ff71b9f0b2 33 fields · synced May 30, 2026