EUDAMED last updated this device on Jun 12, 2026

A1K0000000X9001

50596230DP000000000H838U

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Stafford-Miller (Ireland) Limited
UDI-DI code: 05054563013699
Reference / catalog number: A1K0000000X9001

A1K0000000X9001 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Stafford-Miller (Ireland) Limited. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

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Date of registration
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EUDAMED last updated this device on Jun 12, 2026

A1K0000000X9001

50596230DP000000000H838U

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Stafford-Miller (Ireland) Limited
UDI-DI code: 05054563013699
Reference / catalog number: A1K0000000X9001

View device family (Basic UDI)

Device identification

Trade name: not provided
UDI-DI code: 05054563013699
Basic UDI-DI: 50596230DP000000000H838U
Reference / catalog number: A1K0000000X9001
Issuing entity: GS1

Classification

Risk category: Class IIa
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)05054563013699

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.

Q010280PROSTHETIC DENTISTRY DEVICES - ACCESSORIES

Critical warnings

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

CW999
Other side effects such as oral irritations and gastrointestinal symptoms (e.g. nausea) may occur
CW999
A few individuals may be sensitive or allergic to this product. If you experience an allergic reaction or discomfort, discontinue use immediately

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 Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05054563013699
Basic UDI-DI: 50596230DP000000000H838U
Reference / catalog number: A1K0000000X9001
Issuing entity: GS1

Classification

Risk category: Class IIa
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: Stafford-Miller (Ireland) Limited
SRN: IE-MF-000002788
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05054563013699

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.

Q010280PROSTHETIC DENTISTRY DEVICES - ACCESSORIES

Critical warnings

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

CW999
Other side effects such as oral irritations and gastrointestinal symptoms (e.g. nausea) may occur
CW999
A few individuals may be sensitive or allergic to this product. If you experience an allergic reaction or discomfort, discontinue use immediately

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.

GB23/00000413Issued
Quality management systemNotified body: 1639Expiry: Dec 8, 2028

Certificates covering this device

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

All products by Stafford-Miller (Ireland) Limited

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement		Still on market

A1K0000000X9001

A1K0000000X9001

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

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