FDA Registration Active 🇨🇳 China

Sterile Disposable Temperature

Reg #: 3007773209 · FEI: 3007773209 · Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1

Registration Details

Registration Name
SHENZHEN ENVISEN INDUSTRY CO. LTD.
Registration Number
3007773209
FEI Number
3007773209
Status
Active
Expiry Year
2025
Initial Importer
No
Address
Block 1, 40 Jianlong Street, Bao'an Community, Yuanshan Town, Long Gang District
City
SHENZHEN Guangdong
Country
CN

Regulatory Submissions

510(k) Number
K212945

Owner / Operator

Firm Name
Shenzhen ENVISEN Industry Co. Ltd.
Operator Number
9082060
Address
Block 1, 40 Jianlong Street, Bao'an Community, Yuanshan Town, Long Gang District
City
SHENZHEN
State
Guangdong
Postal Code
518115
Country
CN

US Agent

Business Name
Imagenix, Inc.
Contact Name
Stephen Gorski
Address
S65W35739 Piper Road
City
Eagle
State
WI
ZIP
53119
Country
US
Phone
414 7374596

Products

Device Name Product Code
Continuous Measurement Thermometer FLL

Proprietary Names

Sterile Disposable Temperature

Establishment Types

Manufacture Medical Device