Spectralis, Hep

FDA UDI

Class I (US FDA UDI)

by Heidelberg Engineering

Identity

Trade Name: SPECTRALIS, HEP FDA UDI
Generic Name: Perimeter, automatic FDA UDI
Model / Reference: Image Capture Module SW V1.2.4 FDA UDI

Identifiers

Primary DI / UDI-DI: 04059237000396 FDA UDI
FDA Product Code: HOO FDA UDI
OBO FDA UDI
MYC FDA UDI
GMDN Term: Perimeter, automatic FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.1605 FDA UDI
886.1570 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

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ophthalmic spectral-domain optical coherence tomography system Perimeter, automatic Scanning-laser retinal imaging system

Spectralis, Hep by Heidelberg Engineering — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Heidelberg Engineering

Sources (1)

FDA UDI 9ab328b4-2a25-45ed-adaf-dd230891b80e 32 fields · synced May 30, 2026