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Accutrans

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 22-000948-21Model AT 4812-3

by Bioptimal International PTE. LTD.

Identity

Trade Name
Accutrans EUDAMED
ACCUTRANS Disposable Pressure Monitoring Kit FDA UDI
Generic Name
Invasive blood pressure transducer set FDA UDI
Device Name
Pressure Monitoring Systems and Kits, Accutrans EUDAMED
Model / Reference
AT 4812-3 EUDAMED
22-000948-21 EUDAMED
AT 4812-3 - 22-000948-21 FDA UDI

Identifiers

Catalog Number
22-000948-21 FDA UDI
Primary DI / UDI-DI
08886483504257 EUDAMEDFDA UDI
Basic UDI-DI
B-08886483504257 EUDAMED
FDA Product Code
DRS FDA UDI
EMDN Code
Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
GMDN Term
Invasive blood pressure transducer set FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
870.2850 FDA UDI
Market of Registration
Germany 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
MRI Safety
MR Conditional FDA UDI

Accutrans by Bioptimal International Pte. 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
Bioptimal International PTE. LTD.
EUDAMED SRN
SG-MF-000010306
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

  • EUDAMED 1e6d1d7d-e2b7-4ae8-b46f-9e0b51c6841a 61 fields · synced May 30, 2026
  • FDA UDI c7019074-f25c-4c74-8447-ecea9e30ea83 35 fields · synced May 30, 2026