EUDAMED last updated this device on May 11, 2026

55mm±2mm

69256340MLC3H

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Suzhou Colour-way New Material Co., Ltd.
UDI-DI code: 06925634024342
Reference / catalog number: 55mm±2mm

55mm±2mm is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Suzhou Colour-way New Material Co., Ltd.. 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 11, 2026

55mm±2mm

69256340MLC3H

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Suzhou Colour-way New Material Co., Ltd.
UDI-DI code: 06925634024342
Reference / catalog number: 55mm±2mm

View device family (Basic UDI)

Device identification

Trade name: not provided
UDI-DI code: 06925634024342
Basic UDI-DI: 69256340MLC3H
Reference / catalog number: 55mm±2mm
Issuing entity: GS1

Classification

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

Device details

Quantity: 250000
Additional product description: Chocolate Flavored, thickness: 0.065±0.015mm
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)06925634024342

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.

U110101CONDOMS

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW129
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 32 countries total.

Country	On market since	Until
GermanyPrimary placement	May 11, 2026	May 11, 2036
Austria	May 11, 2026	May 11, 2036
Belgium	May 11, 2026	May 11, 2036
Bulgaria	May 11, 2026	May 11, 2036
Cyprus	May 11, 2026	May 11, 2036
Czechia	May 11, 2026	May 11, 2036
Denmark	May 11, 2026	May 11, 2036
Estonia	May 11, 2026	May 11, 2036
EL	May 11, 2026	May 11, 2036
Spain	May 11, 2026	May 11, 2036
Finland	May 11, 2026	May 11, 2036
France	May 11, 2026	May 11, 2036
Croatia	May 11, 2026	May 11, 2036
Hungary	May 11, 2026	May 11, 2036
Ireland	May 11, 2026	May 11, 2036
Iceland	May 11, 2026	May 11, 2036
Italy	May 11, 2026	May 11, 2036
Liechtenstein	May 11, 2026	May 11, 2036
Lithuania	May 11, 2026	May 11, 2036
Luxembourg	May 11, 2026	May 11, 2036
Latvia	May 11, 2026	May 11, 2036
Malta	May 11, 2026	May 11, 2036
Netherlands	May 11, 2026	May 11, 2036
Norway	May 11, 2026	May 11, 2036
Poland	May 11, 2026	May 11, 2036
Portugal	May 11, 2026	May 11, 2036
Romania	May 11, 2026	May 11, 2036
Sweden	May 11, 2026	May 11, 2036
Slovenia	May 11, 2026	May 11, 2036
Slovakia	May 11, 2026	May 11, 2036
Türkiye	May 11, 2026	May 11, 2036
XI	May 11, 2026	May 11, 2036

Device identification

Trade name: not provided
UDI-DI code: 06925634024342
Basic UDI-DI: 69256340MLC3H
Reference / catalog number: 55mm±2mm
Issuing entity: GS1

Classification

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

Device details

Quantity: 250000
Additional product description: Chocolate Flavored, thickness: 0.065±0.015mm
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: Suzhou Colour-way New Material Co., Ltd.
SRN: CN-MF-000027396
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06925634024342

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.

U110101CONDOMS

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW129
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.

G10 040345 0025Issued
Quality management systemNotified body: 0123Expiry: Feb 11, 2030

Certificates covering this device

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

All products by Suzhou Colour-way New Material Co., Ltd.

Market distribution

Primary placement in Germany; available across 32 countries total.

Country	On market since	Until
GermanyPrimary placement	May 11, 2026	May 11, 2036
Austria	May 11, 2026	May 11, 2036
Belgium	May 11, 2026	May 11, 2036
Bulgaria	May 11, 2026	May 11, 2036
Cyprus	May 11, 2026	May 11, 2036
Czechia	May 11, 2026	May 11, 2036
Denmark	May 11, 2026	May 11, 2036
Estonia	May 11, 2026	May 11, 2036
EL	May 11, 2026	May 11, 2036
Spain	May 11, 2026	May 11, 2036
Finland	May 11, 2026	May 11, 2036
France	May 11, 2026	May 11, 2036
Croatia	May 11, 2026	May 11, 2036
Hungary	May 11, 2026	May 11, 2036
Ireland	May 11, 2026	May 11, 2036
Iceland	May 11, 2026	May 11, 2036
Italy	May 11, 2026	May 11, 2036
Liechtenstein	May 11, 2026	May 11, 2036
Lithuania	May 11, 2026	May 11, 2036
Luxembourg	May 11, 2026	May 11, 2036
Latvia	May 11, 2026	May 11, 2036
Malta	May 11, 2026	May 11, 2036
Netherlands	May 11, 2026	May 11, 2036
Norway	May 11, 2026	May 11, 2036
Poland	May 11, 2026	May 11, 2036
Portugal	May 11, 2026	May 11, 2036
Romania	May 11, 2026	May 11, 2036
Sweden	May 11, 2026	May 11, 2036
Slovenia	May 11, 2026	May 11, 2036
Slovakia	May 11, 2026	May 11, 2036
Türkiye	May 11, 2026	May 11, 2036
XI	May 11, 2026	May 11, 2036

55mm±2mm

55mm±2mm

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

Related devices