EUDAMED last updated this device on Jan 25, 2026

035.6310S

0763003170108QP

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Institut Straumann AG
UDI-DI code: 07630031765178
Reference / catalog number: 035.6310S

035.6310S is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Institut Straumann AG. 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 Jan 25, 2026

035.6310S

0763003170108QP

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Institut Straumann AG
UDI-DI code: 07630031765178
Reference / catalog number: 035.6310S

View device family (Basic UDI)

Device identification

Trade name: not provided
UDI-DI code: 07630031765178
Basic UDI-DI: 0763003170108QP
Reference / catalog number: 035.6310S
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: TLC SP Implant, Ø 3.75mm RT, SLA® 10mm, Roxolid®
Additional information URL: https://ifu.straumann.com/
Clinical sizes: 3.75 MU50
10 MU50

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)07630031765178

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.

P01020101DENTAL IMPLANTS

Critical warnings

3 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.
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 Germany; available across 27 countries total.

Country	On market since	Until
GermanyPrimary placement	Dec 5, 2022	Still on market
Austria	Dec 5, 2022	Still on market
Belgium	Dec 5, 2022	Still on market
Bulgaria	Dec 5, 2022	Still on market
Cyprus	Dec 5, 2022	Still on market
Czechia	Dec 5, 2022	Still on market
Denmark	Dec 5, 2022	Still on market
Estonia	Dec 5, 2022	Still on market
EL	Dec 5, 2022	Still on market
Spain	Dec 5, 2022	Still on market
Finland	Dec 5, 2022	Still on market
France	Dec 5, 2022	Still on market
Croatia	Dec 5, 2022	Still on market
Hungary	Dec 5, 2022	Still on market
Ireland	Dec 5, 2022	Still on market
Italy	Dec 5, 2022	Still on market
Lithuania	Dec 5, 2022	Still on market
Luxembourg	Dec 5, 2022	Still on market
Latvia	Dec 5, 2022	Still on market
Malta	Dec 5, 2022	Still on market
Netherlands	Dec 5, 2022	Still on market
Poland	Dec 5, 2022	Still on market
Portugal	Dec 5, 2022	Still on market
Romania	Dec 5, 2022	Still on market
Sweden	Dec 5, 2022	Still on market
Slovenia	Dec 5, 2022	Still on market
Slovakia	Dec 5, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: 07630031765178
Basic UDI-DI: 0763003170108QP
Reference / catalog number: 035.6310S
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: TLC SP Implant, Ø 3.75mm RT, SLA® 10mm, Roxolid®
Additional information URL: https://ifu.straumann.com/
Clinical sizes: 3.75 MU50
10 MU50

Manufacturer information

Organization name: Institut Straumann AG
SRN: CH-MF-000009933
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)07630031765178

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.

P01020101DENTAL IMPLANTS

Critical warnings

3 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.
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.

G10 020326 0062Reissued
Quality management systemNotified body: 0123Expiry: Jun 15, 2030
G11 020326 0063Reissued
Quality management systemNotified body: 0123Expiry: May 25, 2030

Certificates covering this device

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

All products by Institut Straumann AG

Market distribution

Primary placement in Germany; available across 27 countries total.

Country	On market since	Until
GermanyPrimary placement	Dec 5, 2022	Still on market
Austria	Dec 5, 2022	Still on market
Belgium	Dec 5, 2022	Still on market
Bulgaria	Dec 5, 2022	Still on market
Cyprus	Dec 5, 2022	Still on market
Czechia	Dec 5, 2022	Still on market
Denmark	Dec 5, 2022	Still on market
Estonia	Dec 5, 2022	Still on market
EL	Dec 5, 2022	Still on market
Spain	Dec 5, 2022	Still on market
Finland	Dec 5, 2022	Still on market
France	Dec 5, 2022	Still on market
Croatia	Dec 5, 2022	Still on market
Hungary	Dec 5, 2022	Still on market
Ireland	Dec 5, 2022	Still on market
Italy	Dec 5, 2022	Still on market
Lithuania	Dec 5, 2022	Still on market
Luxembourg	Dec 5, 2022	Still on market
Latvia	Dec 5, 2022	Still on market
Malta	Dec 5, 2022	Still on market
Netherlands	Dec 5, 2022	Still on market
Poland	Dec 5, 2022	Still on market
Portugal	Dec 5, 2022	Still on market
Romania	Dec 5, 2022	Still on market
Sweden	Dec 5, 2022	Still on market
Slovenia	Dec 5, 2022	Still on market
Slovakia	Dec 5, 2022	Still on market

035.6310S

035.6310S

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