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SansaTM

FDA UDI

Class II (US FDA UDI)

by Huxley Medical

Identity

Trade Name
SansaTM FDA UDI
Generic Name
Wearable multiple physiological parameter recorder, reusable FDA UDI
Model / Reference
1000-00 FDA UDI

Identifiers

Primary DI / UDI-DI
G2331000000 FDA UDI
FDA Product Code
MNR FDA UDI
BZQ FDA UDI
GMDN Term
Wearable multiple physiological parameter recorder, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.2375 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Wearable multiple physiological parameter recorder, reusable

SansaTM by Huxley Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wearable multiple physiological parameter recorder, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Huxley Medical

Sources (1)

  • FDA UDI 2eebdc7a-115d-477a-9952-3271a73d1cf1 32 fields · synced May 29, 2026