EUDAMED last updated this device on Mar 18, 2026

5000403TST

805573143VCA0TIT.ASTR.SLA

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Mikai s.p.a.
UDI-DI code: 08055731432783
Reference / catalog number: 5000403TST

View device family (Basic UDI)

Role
Country
Date of registration
Address

EUDAMED last updated this device on Mar 18, 2026

5000403TST

805573143VCA0TIT.ASTR.SLA

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Mikai s.p.a.
UDI-DI code: 08055731432783
Reference / catalog number: 5000403TST

View device family (Basic UDI)

Device identification

Trade name: not provided
UDI-DI code: 08055731432783
Basic UDI-DI: 805573143VCA0TIT.ASTR.SLA
Reference / catalog number: 5000403TST
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://www.mikai.us/downloads/
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)08055731432783

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.

P09120699BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW007
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 Italy; available across 9 countries total.

Country	On market since	Until
ItalyPrimary placement		Still on market
Germany		Still on market
EL		Still on market
Spain		Still on market
Croatia		Still on market
Ireland		Still on market
Poland		Still on market
Portugal		Still on market
Slovakia		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08055731432783
Basic UDI-DI: 805573143VCA0TIT.ASTR.SLA
Reference / catalog number: 5000403TST
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://www.mikai.us/downloads/
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: Mikai s.p.a.
SRN: IT-MF-000030732
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08055731432783

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.

P09120699BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW007
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.

ITH 1343576 1Issued
Quality management systemNotified body: 1936Expiry: Jan 23, 2030

Certificates covering this device

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

Market distribution

Primary placement in Italy; available across 9 countries total.

Country	On market since	Until
ItalyPrimary placement		Still on market
Germany		Still on market
EL		Still on market
Spain		Still on market
Croatia		Still on market
Ireland		Still on market
Poland		Still on market
Portugal		Still on market
Slovakia		Still on market

5000403TST

5000403TST

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