Identity
- Trade Name
- Millex-HA EUDAMEDFDA UDI
- Generic Name
- Syringe filter, clinical FDA UDI
- Device Name
- Millex-HA Filter Unit EUDAMED
- Model / Reference
- SLHAM33SS EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04054839076596 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04054839076596 EUDAMED
- FDA Product Code
- BSN FDA UDI
- EMDN Code
- A04010101 WITHDRAWL AND ADMINISTRATION FILTERS (0.2-1.2 MICRONS) EUDAMED
- GMDN Term
- Syringe filter, clinical FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5130 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Millex-HA by Merck Millipore Ltd — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04054839076596 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Merck Millipore Ltd
- EUDAMED SRN
- IE-MF-000003997
Sources (2)
- EUDAMED 9742dd93-e12f-472e-a3b5-bd18afc80004 61 fields · synced Jun 19, 2026
- FDA UDI 0bddfd39-8a68-472d-a9a8-891917d8e1cd 32 fields · synced May 30, 2026