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Millex-HV

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref OEM980903

by Merck Millipore Ltd

Identity

Trade Name
Millex-HV EUDAMEDFDA UDI
Generic Name
Syringe filter, clinical FDA UDI
Device Name
Millex-HV Filter Unit EUDAMED
Model / Reference
OEM980903 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
04054839076329 EUDAMEDFDA UDI
Basic UDI-DI
B-04054839076329 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 EUDAMED
Class 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

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Manufacturer

Manufacturer
Merck Millipore Ltd
EUDAMED SRN
IE-MF-000003997

Sources (2)

  • EUDAMED 5bfff732-b2c8-46e3-834a-c07eea8d91a1 61 fields · synced Sep 30, 2026
  • FDA UDI e072a23c-0195-41d3-a811-177d6a56fcce 32 fields · synced May 30, 2026