EUDAMED last updated this device on May 12, 2026

Sterile Surgical Incision Drapes

697548989XLG042W

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Shandong Shinrise Medical Supplies Co., Ltd.
UDI-DI code: 06975489891781
Reference / catalog number: G04100200

Sterile Surgical Incision Drapes is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Shandong Shinrise Medical Supplies 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 12, 2026

Sterile Surgical Incision Drapes

697548989XLG042W

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Shandong Shinrise Medical Supplies Co., Ltd.
UDI-DI code: 06975489891781
Reference / catalog number: G04100200

View device family (Basic UDI)

Device identification

Trade name: Sterile Surgical Incision Drapes
UDI-DI code: 06975489891781
Basic UDI-DI: 697548989XLG042W
Reference / catalog number: G04100200
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: 20
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 10cm×20cm

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06975489891781

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.

T02010101INCISION DRAPES, WITHOUT ANTIBACTERIAL AGENT

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW032
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	Jan 1, 2026	Still on market

Device identification

Trade name: Sterile Surgical Incision Drapes
UDI-DI code: 06975489891781
Basic UDI-DI: 697548989XLG042W
Reference / catalog number: G04100200
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: 20
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 10cm×20cm

Manufacturer information

Organization name: Shandong Shinrise Medical Supplies Co., Ltd.
SRN: CN-MF-000031315
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06975489891781

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.

T02010101INCISION DRAPES, WITHOUT ANTIBACTERIAL AGENT

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW032
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.

HZ 2438964-1Issued
Quality management systemNotified body: 0197Expiry: Nov 21, 2029

Certificates covering this device

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

All products by Shandong Shinrise Medical Supplies Co., Ltd.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jan 1, 2026	Still on market

Sterile Surgical Incision Drapes

Sterile Surgical Incision Drapes

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