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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

FD12 — Class IIa MDR by Cavex Holland BV

MD Atlas
Cavex Holland BV

EUDAMED last updated this device on Jul 7, 2023

FD12

++E241FD000PB

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Cavex Holland BV
UDI-DI code: E241FD120
Reference / catalog number: FD12

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View device family (Basic UDI)

Manufacturer information

Organization name: Cavex Holland BV
SRN: NL-MF-000000423
Manufacturer status: Active

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Certificates

Certificate health across this manufacturer's portfolio.

HZ 1710455-1Issued
Quality management systemNotified body: 0197Expiry: Oct 15, 2026

Critical warnings

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

CW043
EUDAMED did not publish a description for this code.
CW083
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Netherlands; available across 2 countries total.

Country	On market since	Until
NetherlandsPrimary placement		Still on market
Germany		Still on market

Device identification

Trade name: not provided
UDI-DI code: E241FD120
Basic UDI-DI: ++E241FD000PB
Reference / catalog number: FD12
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: syringe OA2
Additional information URL: https://www.cavex.nl/wp-content/uploads/2021/12/IFU-Quadrant-Flow-ZF728.11-Multi.pdf
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

E241FD120

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Q01010103DENTAL RESTORATIVE COMPOSITES

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

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