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HEINE diSTANCE

FDA UDI

Class I (US FDA UDI)

by Heine Optotechnik GmbH & Co. KG

Identity

Trade Name
HEINE diSTANCE FDA UDI
Generic Name
Dermatoscope, optical FDA UDI
Device Name
Contact plate FDA UDI
Model / Reference
000 FDA UDI
Description
Contact plate FDA UDI

Identifiers

Catalog Number
K-000.34.103 FDA UDI
Primary DI / UDI-DI
04053755201587 FDA UDI
FDA Product Code
KYT FDA UDI
GMDN Term
Dermatoscope, optical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6350 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dermatoscope, optical

HEINE diSTANCE by Heine Optotechnik GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dermatoscope, optical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Heine Optotechnik GmbH & Co. KG

Sources (1)

  • FDA UDI da9cd1b7-51d1-4c01-a6de-e440dcf958a8 35 fields · synced Jun 7, 2026