EUDAMED last updated this device on May 25, 2026

AZ-TR100

697310523SplintFA

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Anping Guardian Medical Equipment Co., Ltd
UDI-DI code: 06973105230129
Reference / catalog number: AZ-TR100

AZ-TR100 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Anping Guardian Medical Equipment 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 25, 2026

AZ-TR100

697310523SplintFA

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Anping Guardian Medical Equipment Co., Ltd
UDI-DI code: 06973105230129
Reference / catalog number: AZ-TR100

View device family (Basic UDI)

Device identification

Trade name: not provided
UDI-DI code: 06973105230129
Basic UDI-DI: 697310523SplintFA
Reference / catalog number: AZ-TR100
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: 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)06973105230129

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.

M03050299BANDAGES AND SPLINTS - OTHER

Critical warnings

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

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 32 countries total.

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

Device identification

Trade name: not provided
UDI-DI code: 06973105230129
Basic UDI-DI: 697310523SplintFA
Reference / catalog number: AZ-TR100
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: No clinical sizes registered for this device.

Manufacturer information

Organization name: Anping Guardian Medical Equipment Co., Ltd
SRN: CN-MF-000015025
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06973105230129

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.

M03050299BANDAGES AND SPLINTS - OTHER

Critical warnings

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

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.

HZ 2594005-1Issued
Quality management systemNotified body: 0197Expiry: Oct 8, 2030

Certificates covering this device

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

All products by Anping Guardian Medical Equipment Co., Ltd

Market distribution

Primary placement in Germany; available across 32 countries total.

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

AZ-TR100

AZ-TR100

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