EUDAMED last updated this device on Jun 7, 2026

048.960V4

0763003170013QB

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Institut Straumann AG
UDI-DI code: 07630031726513
Reference / catalog number: 048.960V4

048.960V4 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. 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 Jun 7, 2026

048.960V4

0763003170013QB

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Institut Straumann AG
UDI-DI code: 07630031726513
Reference / catalog number: 048.960V4

View device family (Basic UDI)

Device identification

Trade name: not provided
UDI-DI code: 07630031726513
Basic UDI-DI: 0763003170013QB
Reference / catalog number: 048.960V4
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: 4
Additional product description: NNC Bite registration aid, H 8mm, POM
Additional information URL: https://ifu.straumann.com/
Clinical sizes: 8 MU50

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)07630031726513

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.

P01020180DENTAL IMPLANTS - ACCESSORIES

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW265
EUDAMED did not publish a description for this code.
CW009
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	May 8, 2012	Still on market
Austria	May 8, 2012	Still on market
Belgium	May 8, 2012	Still on market
Bulgaria	May 8, 2012	Still on market
Cyprus	May 8, 2012	Still on market
Czechia	May 8, 2012	Still on market
Denmark	May 8, 2012	Still on market
Estonia	May 8, 2012	Still on market
EL	May 8, 2012	Still on market
Spain	May 8, 2012	Still on market
Finland	May 8, 2012	Still on market
France	May 8, 2012	Still on market
Croatia	May 8, 2012	Still on market
Hungary	May 8, 2012	Still on market
Ireland	May 8, 2012	Still on market
Italy	May 8, 2012	Still on market
Lithuania	May 8, 2012	Still on market
Luxembourg	May 8, 2012	Still on market
Latvia	May 8, 2012	Still on market
Malta	May 8, 2012	Still on market
Netherlands	May 8, 2012	Still on market
Poland	May 8, 2012	Still on market
Portugal	May 8, 2012	Still on market
Romania	May 8, 2012	Still on market
Sweden	May 8, 2012	Still on market
Slovenia	May 8, 2012	Still on market
Slovakia	May 8, 2012	Still on market

Device identification

Trade name: not provided
UDI-DI code: 07630031726513
Basic UDI-DI: 0763003170013QB
Reference / catalog number: 048.960V4
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: 4
Additional product description: NNC Bite registration aid, H 8mm, POM
Additional information URL: https://ifu.straumann.com/
Clinical sizes: 8 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)07630031726513

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.

P01020180DENTAL IMPLANTS - ACCESSORIES

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW265
EUDAMED did not publish a description for this code.
CW009
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	May 8, 2012	Still on market
Austria	May 8, 2012	Still on market
Belgium	May 8, 2012	Still on market
Bulgaria	May 8, 2012	Still on market
Cyprus	May 8, 2012	Still on market
Czechia	May 8, 2012	Still on market
Denmark	May 8, 2012	Still on market
Estonia	May 8, 2012	Still on market
EL	May 8, 2012	Still on market
Spain	May 8, 2012	Still on market
Finland	May 8, 2012	Still on market
France	May 8, 2012	Still on market
Croatia	May 8, 2012	Still on market
Hungary	May 8, 2012	Still on market
Ireland	May 8, 2012	Still on market
Italy	May 8, 2012	Still on market
Lithuania	May 8, 2012	Still on market
Luxembourg	May 8, 2012	Still on market
Latvia	May 8, 2012	Still on market
Malta	May 8, 2012	Still on market
Netherlands	May 8, 2012	Still on market
Poland	May 8, 2012	Still on market
Portugal	May 8, 2012	Still on market
Romania	May 8, 2012	Still on market
Sweden	May 8, 2012	Still on market
Slovenia	May 8, 2012	Still on market
Slovakia	May 8, 2012	Still on market

048.960V4

048.960V4

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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