EUDAMED last updated this device on May 28, 2026

10 cmx10 cm

697368504SBXSDFN01B5

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: FOMED INDUSTRIES INC.
UDI-DI code: 06973685041108
Reference / catalog number: 10 cmx10 cm

10 cmx10 cm is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by FOMED INDUSTRIES INC.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

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Date of registration
Address

EUDAMED last updated this device on May 28, 2026

10 cmx10 cm

697368504SBXSDFN01B5

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: FOMED INDUSTRIES INC.
UDI-DI code: 06973685041108
Reference / catalog number: 10 cmx10 cm

View device family (Basic UDI)

Device identification

Trade name: not provided
UDI-DI code: 06973685041108
Basic UDI-DI: 697368504SBXSDFN01B5
Reference / catalog number: 10 cmx10 cm
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Non Sterile gauze absorbent pad Primary used for wound cleaning, absorption of exudates.
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)06973685041108

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.

M040201ABSORBENT DRESSINGS WITH CELLULOSE PAD AND NON-WOVEN WRAPS

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 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	Jan 1, 2020	Dec 31, 2099

Device identification

Trade name: not provided
UDI-DI code: 06973685041108
Basic UDI-DI: 697368504SBXSDFN01B5
Reference / catalog number: 10 cmx10 cm
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Non Sterile gauze absorbent pad Primary used for wound cleaning, absorption of exudates.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: FOMED INDUSTRIES INC.
SRN: CN-MF-000012944
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06973685041108

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.

M040201ABSORBENT DRESSINGS WITH CELLULOSE PAD AND NON-WOVEN WRAPS

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.

DZ 2372869-1Issued
Quality assuranceNotified body: 0197Expiry: Jul 16, 2028

Certificates covering this device

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

All products by FOMED INDUSTRIES INC.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jan 1, 2020	Dec 31, 2099

10 cmx10 cm

10 cmx10 cm

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