EUDAMED last updated this device on May 23, 2026

Sterilization Pouches and Reels

697462348137354X

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Shanghai Jianzhong Medical Packaging Co.,Ltd
UDI-DI code: 06974623481031
Reference / catalog number: 1603

View device family (Basic UDI)

Role
Country
Date of registration
Address

EUDAMED last updated this device on May 23, 2026

Sterilization Pouches and Reels

697462348137354X

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Shanghai Jianzhong Medical Packaging Co.,Ltd
UDI-DI code: 06974623481031
Reference / catalog number: 1603

View device family (Basic UDI)

Device identification

Trade name: Sterilization Pouches and Reels
UDI-DI code: 06974623481031
Basic UDI-DI: 697462348137354X
Reference / catalog number: 1603
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 150mm✖70m

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06974623481031

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.

S01020201FLAT STERILISATION REELS, TYVEK/PLASTIC FILM

Critical warnings

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

CW010
The user manual of this product, including the available sterilization methods, pre-use preparations, heat sealing, self-sealing, precautions before and after sterilization, storage conditions, etc., all have detailed explanations. Customers should refer to the user manual when using it.
CW009
This product is a single-use medical 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 32 countries total.

Country	On market since	Until
GermanyPrimary placement	Dec 31, 2021	Dec 31, 2099
Austria	Dec 31, 2021	Dec 31, 2099
Belgium	Dec 31, 2021	Dec 31, 2099
Bulgaria	Dec 31, 2021	Dec 31, 2099
Cyprus	Dec 31, 2021	Dec 31, 2099
Czechia	Dec 31, 2021	Dec 31, 2099
Denmark	Dec 31, 2021	Dec 31, 2099
Estonia	Dec 31, 2021	Dec 31, 2099
EL	Dec 31, 2021	Dec 31, 2099
Spain	Dec 31, 2021	Dec 31, 2099
Finland	Dec 31, 2021	Dec 31, 2099
France	Dec 31, 2021	Dec 31, 2099
Croatia	Dec 31, 2021	Dec 31, 2099
Hungary	Dec 31, 2021	Dec 31, 2099
Ireland	Dec 31, 2021	Dec 31, 2099
Iceland	Dec 31, 2021	Dec 31, 2099
Italy	Dec 31, 2021	Dec 31, 2099
Liechtenstein	Dec 31, 2021	Dec 31, 2099
Lithuania	Dec 31, 2021	Dec 31, 2099
Luxembourg	Dec 31, 2021	Dec 31, 2099
Latvia	Dec 31, 2021	Dec 31, 2099
Malta	Dec 31, 2021	Dec 31, 2099
Netherlands	Dec 31, 2021	Dec 31, 2099
Norway	Dec 31, 2021	Dec 31, 2099
Poland	Dec 31, 2021	Dec 31, 2099
Portugal	Dec 31, 2021	Dec 31, 2099
Romania	Dec 31, 2021	Dec 31, 2099
Sweden	Dec 31, 2021	Dec 31, 2099
Slovenia	Dec 31, 2021	Dec 31, 2099
Slovakia	Dec 31, 2021	Dec 31, 2099
Türkiye	Dec 31, 2021	Dec 31, 2099
XI	Dec 31, 2021	Dec 31, 2099

Device identification

Trade name: Sterilization Pouches and Reels
UDI-DI code: 06974623481031
Basic UDI-DI: 697462348137354X
Reference / catalog number: 1603
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 150mm✖70m

Manufacturer information

Organization name: Shanghai Jianzhong Medical Packaging Co.,Ltd
SRN: CN-MF-000013547
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06974623481031

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.

S01020201FLAT STERILISATION REELS, TYVEK/PLASTIC FILM

Critical warnings

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

CW010
The user manual of this product, including the available sterilization methods, pre-use preparations, heat sealing, self-sealing, precautions before and after sterilization, storage conditions, etc., all have detailed explanations. Customers should refer to the user manual when using it.
CW009
This product is a single-use medical 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

No certificates registered for this manufacturer.

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	Dec 31, 2021	Dec 31, 2099
Austria	Dec 31, 2021	Dec 31, 2099
Belgium	Dec 31, 2021	Dec 31, 2099
Bulgaria	Dec 31, 2021	Dec 31, 2099
Cyprus	Dec 31, 2021	Dec 31, 2099
Czechia	Dec 31, 2021	Dec 31, 2099
Denmark	Dec 31, 2021	Dec 31, 2099
Estonia	Dec 31, 2021	Dec 31, 2099
EL	Dec 31, 2021	Dec 31, 2099
Spain	Dec 31, 2021	Dec 31, 2099
Finland	Dec 31, 2021	Dec 31, 2099
France	Dec 31, 2021	Dec 31, 2099
Croatia	Dec 31, 2021	Dec 31, 2099
Hungary	Dec 31, 2021	Dec 31, 2099
Ireland	Dec 31, 2021	Dec 31, 2099
Iceland	Dec 31, 2021	Dec 31, 2099
Italy	Dec 31, 2021	Dec 31, 2099
Liechtenstein	Dec 31, 2021	Dec 31, 2099
Lithuania	Dec 31, 2021	Dec 31, 2099
Luxembourg	Dec 31, 2021	Dec 31, 2099
Latvia	Dec 31, 2021	Dec 31, 2099
Malta	Dec 31, 2021	Dec 31, 2099
Netherlands	Dec 31, 2021	Dec 31, 2099
Norway	Dec 31, 2021	Dec 31, 2099
Poland	Dec 31, 2021	Dec 31, 2099
Portugal	Dec 31, 2021	Dec 31, 2099
Romania	Dec 31, 2021	Dec 31, 2099
Sweden	Dec 31, 2021	Dec 31, 2099
Slovenia	Dec 31, 2021	Dec 31, 2099
Slovakia	Dec 31, 2021	Dec 31, 2099
Türkiye	Dec 31, 2021	Dec 31, 2099
XI	Dec 31, 2021	Dec 31, 2099

Sterilization Pouches and Reels

Sterilization Pouches and Reels

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