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Greentek

FDA UDI

Class II (US FDA UDI)

by Wuhan Greentek Pty Ltd.

Identity

Trade Name
Greentek FDA UDI
Generic Name
Electroencephalographic electrode cap, single-use FDA UDI
Model / Reference
Flex-Cap BM-FC01-23ST FDA UDI

Identifiers

Primary DI / UDI-DI
06970295340041 FDA UDI
510(k) Number
K200162 FDA UDI
FDA Product Code
GXY FDA UDI
GMDN Term
Electroencephalographic electrode cap, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1320 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Electroencephalographic electrode cap, single-use

Greentek by Wuhan Greentek Pty Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electroencephalographic electrode cap, single-use.

Cleared under the same submission

K200162 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wuhan Greentek Pty Ltd.

Sources (1)

  • FDA UDI 68da0c80-f9bb-47e6-8c1a-6b92f115742b 33 fields · synced May 31, 2026