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Organization name
UDI-DI code
Reference / catalog number

VISUFIT 1000 Platform — Class I MDR by Carl Zeiss Vision GmbH

MD Atlas
Carl Zeiss Vision GmbH

EUDAMED last updated this device on Dec 7, 2025

VISUFIT 1000 Platform

42506686-B01-VF1000P-Q3

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Carl Zeiss Vision GmbH
UDI-DI code: 04250668606663
Reference / catalog number: 000000-2194-446

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Manufacturer information

Organization name: Carl Zeiss Vision GmbH
SRN: DE-MF-000006173
Manufacturer status: Active

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Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: VISUFIT 1000 Platform
UDI-DI code: 04250668606663
Basic UDI-DI: 42506686-B01-VF1000P-Q3
Reference / catalog number: 000000-2194-446
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: http://www.zeiss.com/IFU
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q0299OPHTHALMIC DEVICES - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Certificates

Certificate health across this manufacturer's portfolio.

1000266776Issued
Quality management systemNotified body: 0297Expiry: Oct 27, 2026