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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

330200985 8.5 — Class IIa MDR by Ansell Healthcare…

MD Atlas
Ansell Healthcare Europe NV

EUDAMED last updated this device on Mar 6, 2023

330200985 8.5

5414566MGLPFSH3335814H

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ansell Healthcare Europe NV
UDI-DI code: 15414566091853
Reference / catalog number: 330200985 8.5

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Manufacturer information

Organization name: Ansell Healthcare Europe NV
SRN: BE-MF-000000691
Manufacturer status: Active

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.

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Critical warnings

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

CW001
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW011
Product is made from natural rubber latex which can cause allergic reactions

Market distribution

Primary placement in Belgium; available across 2 countries total.

Country	On market since	Until
BelgiumPrimary placement	Jan 5, 2023	Jan 4, 2028
Italy	Jan 5, 2023	Jan 4, 2028

Device identification

Trade name: not provided
UDI-DI code: 15414566091853
Basic UDI-DI: 5414566MGLPFSH3335814H
Reference / catalog number: 330200985 8.5
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://www.ansell.com/gb/en/products/medi-grip-latex-powder-free
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T01010102NON-POWDERED 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

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Expiration date
Manufacturing date
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Software identification