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Organization name
UDI-DI code
Reference / catalog number

619004 — Class I MDR by Bingold GmbH + Co. KG

MD Atlas
Bingold GmbH + Co. KG

EUDAMED last updated this device on Oct 16, 2024

619004

4004034LOC50G7

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Bingold GmbH + Co. KG
UDI-DI code: 04004034619036
Reference / catalog number: 619004

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Manufacturer information

Organization name: Bingold GmbH + Co. KG
SRN: DE-MF-000016561
Manufacturer status: Active

Related devices

420874004034LOC50G7On the market 420864004034LOC50G7On the market 420854004034LOC50G7On the market 420844004034LOC50G7On the market 035044004034NOC35GZOn 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.

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW020
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.

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: not provided
UDI-DI code: 04004034619036
Basic UDI-DI: 4004034LOC50G7
Reference / catalog number: 619004
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: 100
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: XL
black

EMDN nomenclature code(s)

T010201LATEX EXAMINATION / TREATMENT 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