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Centrifree
EUDAMEDFDA UDIClass A (EU MDR)
Ref 4104Model CentrifreeRef 21986643122
Identity
- Trade Name
- Centrifree EUDAMEDFDA UDI
- Generic Name
- Laboratory dialyser FDA UDI
- Device Name
- Centrifree Centrifugal Filter EUDAMED
- Model / Reference
- Centrifree EUDAMED4104 EUDAMEDFDA UDI21986643122 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04054839076046 EUDAMEDFDA UDI04061841767725 EUDAMED
- Basic UDI-DI
- 40548441CSCTN EUDAMED
- Direct Marketing DI
- 04061841767725 EUDAMED
- FDA Product Code
- JJH FDA UDI
- EMDN Code
- W0580 IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES EUDAMED
- GMDN Term
- Laboratory dialyser FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2310 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Centrifree by Merck Millipore Ltd — 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 | 40548441CSCTN | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Merck Millipore Ltd
- EUDAMED SRN
- IE-MF-000003997
Sources (3)
- EUDAMED 65d57b23-02ef-4693-aa0d-4c3a9b810398 61 fields · synced Jul 23, 2026
- EUDAMED 5028cad7-4030-4bda-a03b-6c4f353e8a3c 61 fields · synced May 18, 2026
- FDA UDI c5e9a31c-0fd4-4b8a-8b3c-0a32050aead7 32 fields · synced May 30, 2026