EUDAMED last updated this device on Feb 2, 2022

0034RA-100

++E31216412DU

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Edenta Etablissement
UDI-DI code: E3120034RA1001
Reference / catalog number: 0034RA-100

0034RA-100 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Edenta Etablissement. Placed on the EU market in Liechtenstein. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

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EUDAMED last updated this device on Feb 2, 2022

0034RA-100

++E31216412DU

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Edenta Etablissement
UDI-DI code: E3120034RA1001
Reference / catalog number: 0034RA-100

View device family (Basic UDI)

Device identification

Trade name: not provided
UDI-DI code: E3120034RA1001
Basic UDI-DI: ++E31216412DU
Reference / catalog number: 0034RA-100
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: 100
Additional product description: —
Additional information URL: https://www.edenta.com/
Clinical sizes: 8.5 MU50

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

E3120034RA1001

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.

Q01010403DENTAL ABRASIVE AND POLISHING MATERIALS

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

Market distribution

Primary placement in Liechtenstein; available across 1 country total.

Country	On market since	Until
LiechtensteinPrimary placement	Dec 1, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: E3120034RA1001
Basic UDI-DI: ++E31216412DU
Reference / catalog number: 0034RA-100
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: 100
Additional product description: —
Additional information URL: https://www.edenta.com/
Clinical sizes: 8.5 MU50

Manufacturer information

Organization name: Edenta Etablissement
SRN: LI-MF-000011937
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

E3120034RA1001

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.

Q01010403DENTAL ABRASIVE AND POLISHING MATERIALS

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.

1000183128Issued
Quality management systemNotified body: 0297Expiry: Mar 26, 2030

Legacy certificates

Certificate number: 1000183128
Type: Quality management system
Notified body: DQS Medizinprodukte GmbH (0297)
Validity: Mar 27, 2025 → Mar 26, 2030

Certificates covering this device

1000183128Issued
Quality management systemNotified body: 0297Expiry: Mar 26, 2030

All products by Edenta Etablissement

Market distribution

Primary placement in Liechtenstein; available across 1 country total.

Country	On market since	Until
LiechtensteinPrimary placement	Dec 1, 2022	Still on market

0034RA-100

0034RA-100

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

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

Legacy certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Legacy certificates

Certificates covering this device

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