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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

71003128 — Class I MDR by OPTOMIC ESPAÑA S.A

MD Atlas
OPTOMIC ESPAÑA S.A

EUDAMED last updated this device on Nov 11, 2024

71003128

84360415804142Y

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: OPTOMIC ESPAÑA S.A
UDI-DI code: 08436041580171
Reference / catalog number: 71003128

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Manufacturer information

Organization name: OPTOMIC ESPAÑA S.A
SRN: ES-MF-000003235
Manufacturer status: Active

Market distribution

Primary placement in Spain; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08436041580171
Basic UDI-DI: 84360415804142Y
Reference / catalog number: 71003128
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: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z1201118099INSTRUMENTS FOR OPERATIVE MICROSCOPY - HARDWARE ACCESSORIES - 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

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Certificates

Certificate health across this manufacturer's portfolio.

G10 034400 0017Issued
Quality management systemNotified body: 0123Expiry: Aug 1, 2029