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Everion+ System Adjustable Armband

FDA UDI

Class II (US FDA UDI)

by Biofourmis Singapore Pte., Ltd.

Identity

Trade Name
Everion+ System Adjustable Armband FDA UDI
Generic Name
Wearable multiple physiological parameter recorder, reusable FDA UDI
Model / Reference
EVR-PD-AAB FDA UDI

Identifiers

Primary DI / UDI-DI
08885018690090 FDA UDI
510(k) Number
K213863 FDA UDI
FDA Product Code
MWI FDA UDI
MSX FDA UDI
GMDN Term
Wearable multiple physiological parameter recorder, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2300 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Wearable multiple physiological parameter recorder, reusable

Everion+ System Adjustable Armband by Biofourmis Singapore Pte., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wearable multiple physiological parameter recorder, reusable.

Cleared under the same submission

K213863 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biofourmis Singapore Pte., Ltd.

Sources (1)

  • FDA UDI 7c4233ae-ccff-4ab5-aa24-00db7c73ccfd 33 fields · synced May 29, 2026