EUDAMED last updated this device on May 19, 2026

D9A35D21

084352884UD-TEETHVS

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: UNION DENTAL S.A.
UDI-DI code: 08435288460949
Reference / catalog number: D9A35D21

D9A35D21 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by UNION DENTAL S.A.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

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Country
Date of registration
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EUDAMED last updated this device on May 19, 2026

D9A35D21

084352884UD-TEETHVS

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: UNION DENTAL S.A.
UDI-DI code: 08435288460949
Reference / catalog number: D9A35D21

View device family (Basic UDI)

Device identification

Trade name: not provided
UDI-DI code: 08435288460949
Basic UDI-DI: 084352884UD-TEETHVS
Reference / catalog number: D9A35D21
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: ELEDENT Anterior Teeth, Shade A3,5, Mould D21
Additional information URL: https://unidesa-odi.com/descargas/
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)08435288460949

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.

Q01020605TEMPORARY DENTAL PROSTHESES
Q01020603SKELETAL DENTAL PROSTHESES
Q01020602COMBINED DENTAL PROSTHESES
Q01020601MOBILE DENTAL PROSTHESES

Critical warnings

No critical warnings reported for this 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 Spain; available across 32 countries total.

Country	On market since	Until
SpainPrimary placement	Feb 1, 2026	Still on market
Austria	Feb 1, 2026	Still on market
Belgium	Feb 1, 2026	Still on market
Bulgaria	Feb 1, 2026	Still on market
Cyprus	Feb 1, 2026	Still on market
Czechia	Feb 1, 2026	Still on market
Germany	Feb 1, 2026	Still on market
Denmark	Feb 1, 2026	Still on market
Estonia	Feb 1, 2026	Still on market
EL	Feb 1, 2026	Still on market
Finland	Feb 1, 2026	Still on market
France	Feb 1, 2026	Still on market
Croatia	Feb 1, 2026	Still on market
Hungary	Feb 1, 2026	Still on market
Ireland	Feb 1, 2026	Still on market
Iceland	Feb 1, 2026	Still on market
Italy	Feb 1, 2026	Still on market
Liechtenstein	Feb 1, 2026	Still on market
Lithuania	Feb 1, 2026	Still on market
Luxembourg	Feb 1, 2026	Still on market
Latvia	Feb 1, 2026	Still on market
Malta	Feb 1, 2026	Still on market
Netherlands	Feb 1, 2026	Still on market
Norway	Feb 1, 2026	Still on market
Poland	Feb 1, 2026	Still on market
Portugal	Feb 1, 2026	Still on market
Romania	Feb 1, 2026	Still on market
Sweden	Feb 1, 2026	Still on market
Slovenia	Feb 1, 2026	Still on market
Slovakia	Feb 1, 2026	Still on market
Türkiye	Feb 1, 2026	Still on market
XI	Feb 1, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08435288460949
Basic UDI-DI: 084352884UD-TEETHVS
Reference / catalog number: D9A35D21
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: ELEDENT Anterior Teeth, Shade A3,5, Mould D21
Additional information URL: https://unidesa-odi.com/descargas/
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: UNION DENTAL S.A.
SRN: ES-MF-000003189
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08435288460949

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.

Q01020605TEMPORARY DENTAL PROSTHESES
Q01020603SKELETAL DENTAL PROSTHESES
Q01020602COMBINED DENTAL PROSTHESES
Q01020601MOBILE DENTAL PROSTHESES

Critical warnings

No critical warnings reported for this 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

Certificate health across this manufacturer's portfolio.

2025 CR 0043Supplemented
Quality management systemNotified body: 0318Expiry: Feb 9, 2030

Certificates covering this device

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

All products by UNION DENTAL S.A.

Market distribution

Primary placement in Spain; available across 32 countries total.

Country	On market since	Until
SpainPrimary placement	Feb 1, 2026	Still on market
Austria	Feb 1, 2026	Still on market
Belgium	Feb 1, 2026	Still on market
Bulgaria	Feb 1, 2026	Still on market
Cyprus	Feb 1, 2026	Still on market
Czechia	Feb 1, 2026	Still on market
Germany	Feb 1, 2026	Still on market
Denmark	Feb 1, 2026	Still on market
Estonia	Feb 1, 2026	Still on market
EL	Feb 1, 2026	Still on market
Finland	Feb 1, 2026	Still on market
France	Feb 1, 2026	Still on market
Croatia	Feb 1, 2026	Still on market
Hungary	Feb 1, 2026	Still on market
Ireland	Feb 1, 2026	Still on market
Iceland	Feb 1, 2026	Still on market
Italy	Feb 1, 2026	Still on market
Liechtenstein	Feb 1, 2026	Still on market
Lithuania	Feb 1, 2026	Still on market
Luxembourg	Feb 1, 2026	Still on market
Latvia	Feb 1, 2026	Still on market
Malta	Feb 1, 2026	Still on market
Netherlands	Feb 1, 2026	Still on market
Norway	Feb 1, 2026	Still on market
Poland	Feb 1, 2026	Still on market
Portugal	Feb 1, 2026	Still on market
Romania	Feb 1, 2026	Still on market
Sweden	Feb 1, 2026	Still on market
Slovenia	Feb 1, 2026	Still on market
Slovakia	Feb 1, 2026	Still on market
Türkiye	Feb 1, 2026	Still on market
XI	Feb 1, 2026	Still on market

D9A35D21

D9A35D21

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