EUDAMED last updated this device on Jun 5, 2026

1107101L

8431673TLTF402R

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Spinreact S.A.U.
UDI-DI code: 08431673171025
Reference / catalog number: 1107101L

View device family (Basic UDI)

Role
Country
Date of registration
Address

EUDAMED last updated this device on Jun 5, 2026

1107101L

8431673TLTF402R

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Spinreact S.A.U.
UDI-DI code: 08431673171025
Reference / catalog number: 1107101L

View device family (Basic UDI)

Device identification

Trade name: not provided
UDI-DI code: 08431673171025
Basic UDI-DI: 8431673TLTF402R
Reference / catalog number: 1107101L
Issuing entity: GS1

Classification

Risk category: IVDR Class B
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Latex turbidimetry
Additional information URL: https://www.spinreact.com/
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)08431673171025

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.

W01021109C-REACTIVE PROTEIN

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

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates covering this device

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

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Jun 4, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08431673171025
Basic UDI-DI: 8431673TLTF402R
Reference / catalog number: 1107101L
Issuing entity: GS1

Classification

Risk category: IVDR Class B
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Latex turbidimetry
Additional information URL: https://www.spinreact.com/
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: Spinreact S.A.U.
SRN: ES-MF-000011023
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08431673171025

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.

W01021109C-REACTIVE PROTEIN

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

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates

Certificate health across this manufacturer's portfolio.

HX 1552211-1Issued
Quality management systemNotified body: 0197Expiry: Feb 4, 2030

Certificates covering this device

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

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Jun 4, 2026	Still on market

1107101L

1107101L

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

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

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Related devices