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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

PGB-1000 — IVDR Class A IVDR by Proglycan GmbH

MD Atlas
Proglycan GmbH

EUDAMED last updated this device on Oct 15, 2024

PGB-1000

912012638MUXF_HSA01HX

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Proglycan GmbH
UDI-DI code: 09120126380037
Reference / catalog number: PGB-1000

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Manufacturer information

Organization name: Proglycan GmbH
SRN: AT-MF-000029847
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Austria; available across 2 countries total.

Country	On market since	Until
AustriaPrimary placement	Jul 4, 2023	Still on market
Germany	Jul 4, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 09120126380037
Basic UDI-DI: 912012638MUXF_HSA01HX
Reference / catalog number: PGB-1000
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://proglycan.com/application/downloads.php
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01010299SUBSTRATES - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

PGB-200912012638MUXF_HSA01HXOn the market PGB-40912012638MUXF_HSA01HXOn the market

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.