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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

HE21KL — Class IIa MDD by MK-dent GmbH

MD Atlas
MK-dent GmbH

EUDAMED last updated this device on Feb 7, 2023

HE21KL

B-++E490HE21KLNZ

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: MK-dent GmbH
UDI-DI code: ++E490HE21KLNZ
Reference / catalog number: HE21KL

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Manufacturer information

Organization name: MK-dent GmbH
SRN: DE-MF-000010007
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jan 1, 1995	Feb 7, 2023

Device identification

Trade name: not provided
UDI-DI code: ++E490HE21KLNZ
Basic UDI-DI: B-++E490HE21KLNZ
Reference / catalog number: HE21KL
Issuing entity: HIBCC

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on 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)

Q010199CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - 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

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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.