Identity
- Trade Name
- Millex-HV EUDAMEDFDA UDI
- Generic Name
- Syringe filter, clinical FDA UDI
- Device Name
- Millex-HV Filter Unit EUDAMED
- Model / Reference
- SLHV033RS EUDAMEDSLHV013SL EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08436037120459 EUDAMED04054839076718 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08436037120459 EUDAMEDB-04054839076718 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Millex-HV 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-08436037120459 | 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 (3)
- EUDAMED 0a83b81c-c4fd-4b7c-a18c-f1f420242532 61 fields · synced Jul 13, 2026
- EUDAMED a18c4a99-6fe5-41b3-9880-1a891f7f5b01 61 fields · synced May 18, 2026
- FDA UDI 346b6f01-68dc-4eaf-83ef-576279048743 32 fields · synced May 30, 2026