EUDAMED last updated this device on Nov 13, 2023

RM649.025HP-12

++E31217761EX

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Edenta Etablissement
UDI-DI code: E312RM649025HP121
Reference / catalog number: RM649.025HP-12

View device family (Basic UDI)

Role
Country
Date of registration
Address

EUDAMED last updated this device on Nov 13, 2023

RM649.025HP-12

++E31217761EX

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Edenta Etablissement
UDI-DI code: E312RM649025HP121
Reference / catalog number: RM649.025HP-12

View device family (Basic UDI)

Device identification

Trade name: not provided
UDI-DI code: E312RM649025HP121
Basic UDI-DI: ++E31217761EX
Reference / catalog number: RM649.025HP-12
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: 12
Additional product description: —
Additional information URL: https://www.edenta.com/
Clinical sizes: 2.5 MU50

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

E312RM649025HP121

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.

L159007ODONTOSTOMATOLOGY BURS, REUSABLE

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, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: E312RM649025HP121
Basic UDI-DI: ++E31217761EX
Reference / catalog number: RM649.025HP-12
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: 12
Additional product description: —
Additional information URL: https://www.edenta.com/
Clinical sizes: 2.5 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

E312RM649025HP121

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.

L159007ODONTOSTOMATOLOGY BURS, REUSABLE

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

Certificates covering this device

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

Market distribution

Primary placement in Liechtenstein; available across 1 country total.

Country	On market since	Until
LiechtensteinPrimary placement	Dec 1, 2023	Still on market

RM649.025HP-12

RM649.025HP-12

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

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Certificates covering this device

Related devices