Pure Global

ISE Calibration - India CDSCO Medical Device Registration

ISE Calibration is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000287_f8d8543d640d715253cc40fcbc72a5f6_72900ad091e56ef21dad6b605d38be5c. This device is marketed under the brand name Na+, K+,Cl-,Ca++, pH. The license holder is Edif Medical Systems, and it is classified as Device Class Class B. The approving authority is CDSCO.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database
Powered by Pure Global AI
CDSCO Registered
Class Class B
ISE Calibration
UID: IMP/IVD/2019/000287_f8d8543d640d715253cc40fcbc72a5f6_72900ad091e56ef21dad6b605d38be5c

Brand Name

Na+, K+,Cl-,Ca++, pH

License Holder

Edif Medical Systems

Device Class

Class B

Approving Authority

CDSCO

Product Information

Calibration solution of biochemistry analyzers SFRI ISE 2000, 3000,4000,4500, 5000 and 6000, for sodium, potassium, chloride, calcium and pH

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Similar Products (10)
Other products with the same name or brand

Li Filling Solution

Brand: Na+, K+,Cl-,Ca++, pH

Edif Medical Systems

Class B

Ca Filling Solution

Brand: Na+, K+,Cl-,Ca++, pH

Edif Medical Systems

Class B

SFRI Reagent Pack for ISE 4500

Brand: Na+, K+,Cl-,Ca++, pH

Edif Medical Systems

Class B

BloodTrol 22

Brand: Na+, K+,Cl-,Ca++, pH

Edif Medical Systems

Class B

SFRI CleanEZ 3.1

Brand: Na+, K+,Cl-,Ca++, pH

Edif Medical Systems

Class B

Reference Filling Solution

Brand: Na+, K+,Cl-,Ca++, pH

Edif Medical Systems

Class B

SFRI Reagent Pack for ISE 6000

Brand: Na+, K+,Cl-,Ca++, pH

Edif Medical Systems

Class B

SFRI Clair 3.1

Brand: Na+, K+,Cl-,Ca++, pH

Edif Medical Systems

Class B

SFRI Diluent 5.1

Brand: Na+, K+,Cl-,Ca++, pH

Edif Medical Systems

Class B

SFRI LYSE 3.3

Brand: Na+, K+,Cl-,Ca++, pH

Edif Medical Systems

Class B
Other Products from Edif Medical Systems
Products from the same license holder (10 products)

SARS-Cov-2 Fluorescent PCR

Brand: Maccura

Class C

FLUSH SOLUTION

Class C

Cal Catridge GASTAT 700 MODEL (GASTAT 710, GASTAT 730 & GASTAT 735 GASTAT1800 & GASTAT 1802

Class C

Li Filling Solution

Brand: Na+, K+,Cl-,Ca++, pH

Class B

Ca Filling Solution

Brand: Na+, K+,Cl-,Ca++, pH

Class B

SFRI Reagent Pack for ISE 4500

Brand: Na+, K+,Cl-,Ca++, pH

Class B

Electrolyte Analyzer "ISE 4000"

Brand: SFRI

Class A

BloodTrol 22

Brand: Na+, K+,Cl-,Ca++, pH

Class B

SFRI CleanEZ 3.1

Brand: Na+, K+,Cl-,Ca++, pH

Class B

Reference Filling Solution

Brand: Na+, K+,Cl-,Ca++, pH

Class B