NeedleView CH Scope Kit

FDA UDI

Class II (US FDA UDI)

by Biovision Technologies, Llc

Identity

Trade Name: NeedleView CH Scope Kit FDA UDI
Generic Name: Endoscopic video imaging system FDA UDI
Device Name: 3.4mm Disposable NeedleView CH Scope with Accessories FDA UDI
Model / Reference: BVTKIT82-34001 FDA UDI
Description: 3.4mm Disposable NeedleView CH Scope with Accessories FDA UDI

Identifiers

Catalog Number: BVTKIT82-34001 FDA UDI
Primary DI / UDI-DI: 00851582006030 FDA UDI
FDA Product Code: GCJ FDA UDI
HRX FDA UDI
GMDN Term: Endoscopic video imaging system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
888.1100 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 3.4 Millimeter FDA UDI

Category: Endoscopic video imaging system

NeedleView CH Scope Kit by Biovision Technologies, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Biovision Technologies, Llc

Sources (1)

FDA UDI 1bd286e3-416a-4b92-9ddd-a1f0ec70e516 36 fields · synced May 30, 2026