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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

PROVEO 8 - Ceiling Mount — Class I MDR by Leica Microsystems…

MD Atlas
Leica Microsystems (Schweiz) AG

EUDAMED last updated this device on Nov 21, 2025

PROVEO 8 - Ceiling Mount

76300035PROVEO8RV

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Leica Microsystems (Schweiz) AG
UDI-DI code: 07630003587937
Reference / catalog number: 10448811

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Manufacturer information

Organization name: Leica Microsystems (Schweiz) AG
SRN: CH-MF-000021185
Manufacturer status: Active

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Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW011
Do not use in microsurgery (Neurosurgery, Plastic/Reconstructive, Ear, Nose and Throat surgeries).
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: PROVEO 8 - Ceiling Mount
UDI-DI code: 07630003587937
Basic UDI-DI: 76300035PROVEO8RV
Reference / catalog number: 10448811
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: Ceiling swingarm for PROVEO 8 - for Leica surgical operating microscope: PROVEO 8 CT42
Additional information URL: https://www.leica-microsystems.com/products/surgical-microscopes/p/proveo-8/downloads/#t3m-ProductArticle-downloadCategory-Proveo8-UserManuals/IFUs
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12011101OPERATIVE MICROSCOPES

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

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.