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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

Ceramir CAD/CAM i-BLOCK (øS) A3 — Class IIa MDR

MD Atlas
edelweiss dentistry products gmbh

EUDAMED last updated this device on Apr 21, 2026

Ceramir CAD/CAM i-BLOCK (øS) A3

912004632iBlockSK

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: edelweiss dentistry products gmbh
UDI-DI code: 09120046326719
Reference / catalog number: 805196

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Manufacturer information

Organization name: edelweiss dentistry products gmbh
SRN: AT-MF-000005413
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.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
If known allergies to any of the components.

Market distribution

Primary placement in Sweden; available across 1 country total.

Country	On market since	Until
SwedenPrimary placement	Apr 30, 2024	Still on market

Device identification

Trade name: Ceramir CAD/CAM i-BLOCK (øS) A3
UDI-DI code: 09120046326719
Basic UDI-DI: 912004632iBlockSK
Reference / catalog number: 805196
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: 5
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)

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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Software identification