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STA® - Unicalibrator

EUDAMEDFDA UDI

Class C (EU MDR)

Ref 00675

by Diagnostica Stago

Identity

Trade Name
STA® - Unicalibrator EUDAMEDFDA UDI
Generic Name
Multiple coagulation factor IVD, calibrator FDA UDI
Device Name
STA® - Unicalibrator EUDAMED
Model / Reference
00675 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
13607450006756 EUDAMEDFDA UDI
Basic UDI-DI
3607450CALG0002AN EUDAMED
Unit of Use DI
03607450006759 EUDAMED
510(k) Number
K922021 FDA UDI
FDA Product Code
GIZ FDA UDI
EMDN Code
W0103020701 CALIBRATION PLASMA FOR HAEMOSTASIS EUDAMED
GMDN Term
Multiple coagulation factor IVD, calibrator FDA UDI

Classification

Device Class
Class C EUDAMED
Class II FDA UDI
Regulation Number
864.5425 FDA UDI
Market of Registration
France 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

Yes

EUDAMED

Animal Tissues

Yes

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

Yes

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

STA® - Unicalibrator by Diagnostica Stago — Class C — 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

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Manufacturer

Manufacturer
Diagnostica Stago
EUDAMED SRN
FR-MF-000017089

Sources (2)

  • EUDAMED 01489711-5275-4f4e-a26b-a9ae743f6f26 61 fields · synced Jul 26, 2026
  • FDA UDI bae28d89-361e-4253-932f-0c5364fe1e1c 34 fields · synced May 29, 2026