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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

ZFX05001961 — Class I MDR by Zfx GmbH

MD Atlas
Zfx GmbH

EUDAMED last updated this device on May 4, 2026

ZFX05001961

42518817-AM-I-Scanbody-YW

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Zfx GmbH
UDI-DI code: 04251881763386
Reference / catalog number: ZFX05001961

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Manufacturer information

Organization name: Zfx GmbH
SRN: DE-MF-000018101
Manufacturer status: Active

Critical warnings

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

CW011
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04251881763386
Basic UDI-DI: 42518817-AM-I-Scanbody-YW
Reference / catalog number: ZFX05001961
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: 1
Additional product description: INTRA-AS-OS-MACH-3.5-4.0-H7
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 3.5–4 MU50
7 MU50

EMDN nomenclature code(s)

Q01010199DENTAL RESTORATION 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

Related devices

ZFX05Z-ZB-CE-3442518817-GT-D-Scanbody-D7On the market ZFX02HLD3642518817-GT-Tool-6DOn the market ZFX02HLD2842518817-GT-Tool-6DOn the market ZFX02HLD2142518817-GT-Tool-6DOn the market ZFX05Z-ZB-TSV-3542518817-GT-D-Scanbody-D7On 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.