← Back to catalogue

alpHaONE

FDA UDI

Class I (US FDA UDI)

by Chongqing Jinshan Science & Technology (Group) Co., Ltd

Identity

Trade Name
alpHaONE FDA UDI
Generic Name
Gastrointestinal telemetric monitoring system capsule, ingestible FDA UDI
Device Name
pH capsule, 1 pack FDA UDI
Model / Reference
JSPC-1 FDA UDI
Description
pH capsule, 1 pack FDA UDI

Identifiers

Primary DI / UDI-DI
06946332800045 FDA UDI
FDA Product Code
FFT FDA UDI
GMDN Term
Gastrointestinal telemetric monitoring system capsule, ingestible FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.1400 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Gastrointestinal telemetric monitoring system capsule, ingestible

alpHaONE by Chongqing Jinshan Science & Technology (Group) Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastrointestinal telemetric monitoring system capsule, ingestible.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Chongqing Jinshan Science & Technology (Group) Co., Ltd

Sources (1)

  • FDA UDI d410f2fd-1270-40da-b676-3c3ee4c4a50c 36 fields · synced May 30, 2026