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STA R Max®

EUDAMEDFDA UDI

Class A (EU MDR)

Ref 59026Model STA R Max

by Diagnostica Stago

Identity

Trade Name
STA R Max® EUDAMEDFDA UDI
Generic Name
Coagulation analyser IVD, laboratory FDA UDI
Model / Reference
STA R Max EUDAMED
59026 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
03607450590265 EUDAMEDFDA UDI
Basic UDI-DI
3607450INST0004UK EUDAMED
Direct Marketing DI
03607450590265 EUDAMED
510(k) Number
K082675 FDA UDI
K093001 FDA UDI
K151867 FDA UDI
K212183 FDA UDI
K983460 FDA UDI
FDA Product Code
JPA FDA UDI
EMDN Code
W0202029099 VARIOUS HEMOSTASIS INSTRUMENTS - OTHER EUDAMED
GMDN Term
Coagulation analyser IVD, laboratory FDA UDI

Classification

Device Class
Class A EUDAMED
Class II FDA UDI
Regulation Number
864.5425 FDA UDI
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

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

Yes

EUDAMED

New Device

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

STA R Max® by Diagnostica Stago — 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

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Manufacturer

Manufacturer
Diagnostica Stago
EUDAMED SRN
FR-MF-000017089

Sources (2)

  • EUDAMED e56dce1d-f986-4b07-a25f-71608ec8ba00 61 fields · synced May 30, 2026
  • FDA UDI d6ff690a-4515-4d03-93c8-3e084dcccd9f 33 fields · synced May 30, 2026