EUDAMED last updated this device on Nov 16, 2022

The Laerdal Upright Resuscitator

0704543209948TC

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Laerdal Medical AS
UDI-DI code: 07045432092424
Reference / catalog number: LGH-846151

View device family (Basic UDI)

Role
Country
Date of registration
Address

EUDAMED last updated this device on Nov 16, 2022

The Laerdal Upright Resuscitator

0704543209948TC

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Laerdal Medical AS
UDI-DI code: 07045432092424
Reference / catalog number: LGH-846151

View device family (Basic UDI)

Device identification

Trade name: The Laerdal Upright Resuscitator
UDI-DI code: 07045432092424
Basic UDI-DI: 0704543209948TC
Reference / catalog number: LGH-846151
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: ACCESSORIES: Upright OXYGEN KIT The Laerdal Upright Resuscitator (“Upright”) is one self-inflating, reusable manual resuscitator intended for newborns and infants with a body weight of up to 10 kg who need respiratory support.
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)07045432092424

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.

R030280RESPIRATORY BALLONS - ACCESSORIES

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
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 Norway; available across 9 countries total.

Country	On market since	Until
NorwayPrimary placement	Jun 1, 2015	Sep 7, 2027
Austria	Jun 1, 2015	Sep 7, 2027
Belgium	Jun 1, 2015	Sep 7, 2027
Germany	Jun 1, 2015	Sep 7, 2027
France	Jun 1, 2015	Sep 7, 2027
Croatia	Jun 1, 2015	Sep 7, 2027
Italy	Jun 1, 2015	Sep 7, 2027
Netherlands	Jun 1, 2015	Sep 7, 2027
XI	Jun 1, 2015	Sep 7, 2027

Device identification

Trade name: The Laerdal Upright Resuscitator
UDI-DI code: 07045432092424
Basic UDI-DI: 0704543209948TC
Reference / catalog number: LGH-846151
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: ACCESSORIES: Upright OXYGEN KIT The Laerdal Upright Resuscitator (“Upright”) is one self-inflating, reusable manual resuscitator intended for newborns and infants with a body weight of up to 10 kg who need respiratory support.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: Laerdal Medical AS
SRN: NO-MF-000000012
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)07045432092424

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.

R030280RESPIRATORY BALLONS - ACCESSORIES

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
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.

10000470903-PA-NoMA-DNKIssued
Quality management systemNotified body: 2460Expiry: Nov 19, 2026

Certificates covering this device

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

Market distribution

Primary placement in Norway; available across 9 countries total.

Country	On market since	Until
NorwayPrimary placement	Jun 1, 2015	Sep 7, 2027
Austria	Jun 1, 2015	Sep 7, 2027
Belgium	Jun 1, 2015	Sep 7, 2027
Germany	Jun 1, 2015	Sep 7, 2027
France	Jun 1, 2015	Sep 7, 2027
Croatia	Jun 1, 2015	Sep 7, 2027
Italy	Jun 1, 2015	Sep 7, 2027
Netherlands	Jun 1, 2015	Sep 7, 2027
XI	Jun 1, 2015	Sep 7, 2027

The Laerdal Upright Resuscitator

The Laerdal Upright Resuscitator

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