EUDAMED last updated this device on Aug 5, 2026

TSI-S48

697628156DB3E

On the marketClass IIa

Applicable legislation: —
Organization name: FuQuan Toboom Technologies Co., Ltd
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 06976281560257
Reference / catalog number: TSI-S48

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

TSI-S48 is an EU-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by FuQuan Toboom Technologies Co., Ltd. Placed on the EU market in Sweden. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: not provided
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 06976281560257
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: 697628156DB3E
Reference / catalog number: TSI-S48
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: Class IIa
Applicable legislation: —
Status: On the market

Device details

Quantity: 5
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
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

Encoded

(01)06976281560257

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Sweden; available across 9 countries total.

Country	On market since	Until
SwedenPrimary placement	—	Still on market
Bulgaria	—	Still on market
Germany	—	Still on market
France	—	Still on market
Croatia	—	Still on market
Italy	—	Still on market
Poland	—	Still on market
Türkiye	—	Still on market
XI	—	Still on market

Related searches

Class IIa medical devices in EUDAMED

Device identification

Trade name: not provided
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 06976281560257
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: 697628156DB3E
Reference / catalog number: TSI-S48
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Sweden; available across 9 countries total.

Country	On market since	Until
SwedenPrimary placement	—	Still on market
Bulgaria	—	Still on market
Germany	—	Still on market
France	—	Still on market
Croatia	—	Still on market
Italy	—	Still on market
Poland	—	Still on market
Türkiye	—	Still on market
XI	—	Still on market

TSI-S48

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Certificates covering this device

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