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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

FORMALDEHYDE 4% buffered pH 7,2-7,4 — IVDR Class A IVDR

MD Atlas
Ing. Petr Švec - PENTA s.r.o.

EUDAMED last updated this device on Aug 29, 2024

FORMALDEHYDE 4% buffered pH 7,2-7,4

85951422141607A

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Ing. Petr Švec - PENTA s.r.o.
UDI-DI code: 08595142244600
Reference / catalog number: 14160

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Manufacturer information

Organization name: Ing. Petr Švec - PENTA s.r.o.
SRN: CZ-MF-000035988
Manufacturer status: Active

Critical warnings

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

CW083
EUDAMED did not publish a description for this code.
CW088
EUDAMED did not publish a description for this code.
CW093
EUDAMED did not publish a description for this code.
CW094
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Czechia; available across 1 country total.

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

Device identification

Trade name: FORMALDEHYDE 4% buffered pH 7,2-7,4
UDI-DI code: 08595142244600
Basic UDI-DI: 85951422141607A
Reference / catalog number: 14160
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: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01030705FIXING REAGENTS (HISTOLOGY/CYTOLOGY)

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

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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.