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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

K63 — Class I MDD by 3mach GmbH

MD Atlas
3mach GmbH

EUDAMED last updated this device on Apr 17, 2025

K63

B-04251993600906

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: 3mach GmbH
UDI-DI code: 04251993600906
Reference / catalog number: K63

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Manufacturer information

Organization name: 3mach GmbH
SRN: DE-MF-000014407
Manufacturer status: Active

Related devices

1020523-02-25B-04251993601576On the market 1020523-02-2B-04251993601521On the market 1020136-1B-04251993600029On the market 1020139-01B-04251993600036On the market 1000111-7-16B-04251993601064On the market

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: 04251993600906
Basic UDI-DI: B-04251993600906
Reference / catalog number: K63
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Zubehör für die medizinische Instrumentenaufbereitung in Reinigungsmaschinen.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V0799PRODUCTS FOR CLEANING MEDICAL DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

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

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.