Intraoral Scanner

FDA UDIEUDAMED

Class II (US FDA UDI)

by Guangdong Launca Medical Device Technology Co., Ltd.

Identity

Trade Name: Intraoral Scanner FDA UDI
Generic Name: Intraoral optical scanning system FDA UDI
Model / Reference: 1 FDA UDI

Identifiers

Primary DI / UDI-DI: 06973747200085 FDA UDI
FDA Product Code: NOF FDA UDI
GMDN Term: Intraoral optical scanning system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3661 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Intraoral optical scanning system

Intraoral Scanner by Guangdong Launca Medical Device Technology Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED

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Primescan 2 Multiuse Sleeve — Sirona Dental Systems GmbH · Class II
COMFORT+ — D.D.S., Inc. · Class II
PANDA SCANNER — Ziyang Freqty Medical Equipment Co., Ltd. · Class II
INTELLISCAN 3D® Intraoral Scanner — Shining 3D Tech Co., Ltd. · Class II

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Guangdong Launca Medical Device Technology Co., Ltd.

Sources (2)

FDA UDI 74f7fe43-ebfe-46c4-885d-1155d4312c4f 32 fields · synced Jun 20, 2026
EUDAMED 1 fields · synced Jun 1, 2026