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Organization name
UDI-DI code
Reference / catalog number

8000627 — Class I MDR by ANTONI CARLES S.A.

MD Atlas
ANTONI CARLES S.A.

EUDAMED last updated this device on Mar 17, 2022

8000627

8436566191TABGE

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ANTONI CARLES S.A.
UDI-DI code: 08436566192859
Reference / catalog number: 8000627

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Manufacturer information

Organization name: ANTONI CARLES S.A.
SRN: ES-MF-000001010
Manufacturer status: Active

Market distribution

Primary placement in Netherlands; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08436566192859
Basic UDI-DI: 8436566191TABGE
Reference / catalog number: 8000627
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: It is an electrical examination/treatment ophthalmic table height adjustment to hold ophthalmic instrumentation, by providing instrument positioning towards a patient accommodated in a chair to enable diagnosis and treatment.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12129001OPHTHALMOLOGICAL INSTRUMENT STANDS

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

Related devices

42-00000828436566191TABGEOn the market 12290948436566191TABGEOn the market 12291038436566191TABGEOn the market 42-00000808436566191TABGEOn the market 42-00000818436566191TABGEOn the market

Certificates

Certificate health across this manufacturer's portfolio.

HZ 1979224-1Issued
Quality management systemNotified body: 0197Expiry: Oct 16, 2030