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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

Examination disposable gloves,… — Class I MDR by AGBA, v.o.s.

MD Atlas
AGBA, v.o.s.

EUDAMED last updated this device on Apr 7, 2022

Examination disposable gloves, non-sterile, latex containing, dusty

859402080rukaviceFJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: AGBA, v.o.s.
UDI-DI code: 08594020800068
Reference / catalog number: 999001002

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Manufacturer information

Organization name: AGBA, v.o.s.
SRN: CZ-MF-000019455
Manufacturer status: Active

Critical warnings

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

CW129
Latex can cause an allergic reaction, including an anaphylactic reaction

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: Examination disposable gloves, non-sterile, latex containing, dusty
UDI-DI code: 08594020800068
Basic UDI-DI: 859402080rukaviceFJ
Reference / catalog number: 999001002
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: Size L
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T01010101POWDERED LATEX SURGICAL GLOVES

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

Triangular bandage, non-sterile859402080satektrojHHOn 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.