EUDAMED last updated this device on May 18, 2026

M3-RB

697312285UDGRCF003N9

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: United Dental Changzhou
UDI-DI code: 06942135213266
Reference / catalog number: MRB00080021025

M3-RB is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by United Dental Changzhou. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Role
Country
Date of registration
Address

EUDAMED last updated this device on May 18, 2026

M3-RB

697312285UDGRCF003N9

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: United Dental Changzhou
UDI-DI code: 06942135213266
Reference / catalog number: MRB00080021025

View device family (Basic UDI)

Device identification

Trade name: M3-RB
UDI-DI code: 06942135213266
Basic UDI-DI: 697312285UDGRCF003N9
Reference / catalog number: MRB00080021025
Issuing entity: GS1

Classification

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

Device details

Quantity: 6
Additional product description: Root canal file is used with active inslruments designed to cut, flatten, clean and shape teeth and root canals in dental root canal treatment, it contacls dentin or tissue for less than 24 hours. The device is non-sterile Reusable.
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)06942135213266

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.

L159004ENDODONTIC RASPS AND FILES, REUSABLE

Critical warnings

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

CW011
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

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 Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jun 28, 2023	Still on market

Device identification

Trade name: M3-RB
UDI-DI code: 06942135213266
Basic UDI-DI: 697312285UDGRCF003N9
Reference / catalog number: MRB00080021025
Issuing entity: GS1

Classification

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

Device details

Quantity: 6
Additional product description: Root canal file is used with active inslruments designed to cut, flatten, clean and shape teeth and root canals in dental root canal treatment, it contacls dentin or tissue for less than 24 hours. The device is non-sterile Reusable.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: United Dental Changzhou
SRN: CN-MF-000018453
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06942135213266

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.

L159004ENDODONTIC RASPS AND FILES, REUSABLE

Critical warnings

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

CW011
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

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.

DZ 2138755-1Issued
Quality assuranceNotified body: 0197Expiry: Jun 27, 2028

Certificates covering this device

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

All products by United Dental Changzhou

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jun 28, 2023	Still on market

M3-RB

M3-RB

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI 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

UDI-PI 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

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