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Central Hub Speaker

FDA UDIEUDAMED

Class II (US FDA UDI)

by Sibel Health Inc.

Identity

Trade Name
Central Hub Speaker FDA UDI
Generic Name
Wearable multiple vital physiological parameter monitor FDA UDI
Device Name
Central Hub Speaker FDA UDI
Model / Reference
900-00004 FDA UDI
Description
Central Hub Speaker FDA UDI

Identifiers

Primary DI / UDI-DI
00850064210194 FDA UDI
FDA Product Code
MSX FDA UDI
DRG FDA UDI
KMI FDA UDI
MWI FDA UDI
GMDN Term
Wearable multiple vital physiological parameter monitor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2300 FDA UDI
870.2910 FDA UDI
880.2400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Wearable multiple vital physiological parameter monitor

Central Hub Speaker by Sibel Health Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Wearable multiple vital physiological parameter monitor.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sibel Health Inc.

Sources (2)

  • FDA UDI 2e888036-2a36-4db9-8df4-a5abad823cc9 33 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced Jun 19, 2026