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Organization name
UDI-DI code
Reference / catalog number

SPATULA, OPHTHALMIC — Class I MDR by a1 medical GmbH

MD Atlas
a1 medical GmbH

EUDAMED last updated this device on Dec 22, 2021

SPATULA, OPHTHALMIC

42510479PGM000069K

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: a1 medical GmbH
UDI-DI code: 04251047927591
Reference / catalog number: ES-0921

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Manufacturer information

Organization name: a1 medical GmbH
SRN: DE-MF-000006489
Manufacturer status: Active

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: SPATULA, OPHTHALMIC
UDI-DI code: 04251047927591
Basic UDI-DI: 42510479PGM000069K
Reference / catalog number: ES-0921
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: Malbran Strabismus Hook
Additional information URL: https://www.a1-medical.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

L1706OPHTHALMOLOGY SPATULAS, REUSABLE

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

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.