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Organization name
UDI-DI code
Reference / catalog number

VITA ENAMIC® — Class IIa MDR by VITA Zahnfabrik H.…

MD Atlas
VITA Zahnfabrik H. Rauter GmbH & Co. KG

EUDAMED last updated this device on Jul 8, 2024

VITA ENAMIC®

++J017CC0PU

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: VITA Zahnfabrik H. Rauter GmbH & Co. KG
UDI-DI code: J017EC4EC40627650
Reference / catalog number: EC4EC4062765

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Manufacturer information

Organization name: VITA Zahnfabrik H. Rauter GmbH & Co. KG
SRN: DE-MF-000005906
Manufacturer status: Active

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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.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jan 1, 2013	Still on market

Device identification

Trade name: VITA ENAMIC®
UDI-DI code: J017EC4EC40627650
Basic UDI-DI: ++J017CC0PU
Reference / catalog number: EC4EC4062765
Issuing entity: HIBCC

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.vita-zahnfabrik.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q010699MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL 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
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Manufacturing date
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Software identification