EUDAMED last updated this device on Jul 4, 2023

AA035

++E241AA000LX

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Cavex Holland BV
UDI-DI code: E241AA0351
Reference / catalog number: AA035

View device family (Basic UDI)

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Country
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EUDAMED last updated this device on Jul 4, 2023

AA035

++E241AA000LX

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Cavex Holland BV
UDI-DI code: E241AA0351
Reference / catalog number: AA035

View device family (Basic UDI)

Device identification

Trade name: not provided
UDI-DI code: E241AA0351
Basic UDI-DI: ++E241AA000LX
Reference / catalog number: AA035
Issuing entity: HIBCC

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 24
Additional product description: CA37 Fast Set 24x453g
Additional information URL: https://www.cavex.nl/wp-content/uploads/2023/05/2023-05-IFU-Cavex-CA37-EN-AA075IFU.01.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

E241AA0351

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

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EMDN nomenclature code(s)

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

Q01020101DENTAL IMPRESSION ALGINATES

Critical warnings

No critical warnings reported for this device.

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

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

Market distribution

Primary placement in Netherlands; available across 1 country total.

Placed on the market in Netherlands; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: E241AA0351
Basic UDI-DI: ++E241AA000LX
Reference / catalog number: AA035
Issuing entity: HIBCC

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 24
Additional product description: CA37 Fast Set 24x453g
Additional information URL: https://www.cavex.nl/wp-content/uploads/2023/05/2023-05-IFU-Cavex-CA37-EN-AA075IFU.01.pdf
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

E241AA0351

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

By subscribing you accept the Privacy Policy.

EMDN nomenclature code(s)

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

Q01020101DENTAL IMPRESSION ALGINATES

Critical warnings

No critical warnings reported for this device.

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

Certificates

Certificate health across this manufacturer's portfolio.

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

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

Market distribution

Primary placement in Netherlands; available across 1 country total.

Placed on the market in Netherlands; per-country availability dates not published.

AA035

AA035

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Certificates covering this device

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Related devices