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ACCUTRANS™ Disposable Pressure Monitoring System

FDA UDIEUDAMED

Class II (US FDA UDI)

by Bioptimal International Pte. Ltd.

Identity

Trade Name
ACCUTRANS™ Disposable Pressure Monitoring System FDA UDI
Generic Name
Invasive blood pressure transducer set FDA UDI
Model / Reference
AT 4812-3 FDA UDI

Identifiers

Catalog Number
22-000942-03 FDA UDI
Primary DI / UDI-DI
08886483503854 FDA UDI
FDA Product Code
DRS FDA UDI
GMDN Term
Invasive blood pressure transducer set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2850 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Category: Invasive blood pressure transducer set

ACCUTRANS™ Disposable Pressure Monitoring System by Bioptimal International Pte. Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Invasive blood pressure transducer set.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bioptimal International Pte. Ltd.

Sources (2)

  • FDA UDI 6c2276bb-0dbc-490c-98e2-d398e609b6ad 34 fields · synced Oct 7, 2026
  • EUDAMED 1 fields · synced Jun 1, 2026