EUDAMED update: Dec 12, 2025

Haemonetics S.A.

CH-MF-000034549

Active29 devices

Address: Rue de Flecheres, 6 1274 Signy-Centre
Role: Manufacturer
Date of registration: Mar 29, 2023
Country: Switzerland

Haemonetics S.A. is a medical device manufacturer registered in EUDAMED. The company has 29 devices on the EU market across 32 countries. Headquartered in Signy-Centre, Switzerland. Explore the regulatory profile, devices and certificates on MD Atlas.

About HAE SA

: CH-MF-000034549
Role: Manufacturer
Country: Switzerland
Organization name: Haemonetics S.A.
EU VAT number: CHE-107.970.845
Trade register: CHE-107.970.845
Date of registration: Mar 29, 2023

Contact details for HAE SA

Email: regulatoryeurope@haemonetics.com
Address: 6, RUE DE FLECHERES SIGNY CENTRE 1274 SIGNY-CENTRE SWITZERLAND

Competent authority

Name: Ministero della salute - Direzione generale dei dispositivi medici e del servizio farmaceutico

Phone: +39 06 5994 3199/ +39 06 5994 3207
Email: segr.dgfdm@sanita.it

Officers and regulatory representatives of HAE SA

RYAN Julie
The technical documentation and the EU declaration of conformity in respect of the Devices are drawn up and kept up-to date; In the case of investigational devices (if any), the statement referred to in Section 4.1 of Chapter II of Annex XV of the MDR is issued; and In the case of devices for performance studies intended to be used in the context of interventional clinical performance studies, the statement referred to on section 4.1 of Chapter I of Annex XIV of the IVDR is issued.
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KILLION Jim
The conformity of the Devices is appropriately checked, in accordance with the quality management system under which the Devices are manufactured, before each Device is released; The post-market surveillance obligations related to the Devices are complied with in accordance with the Regulations; and The vigilance reporting obligations (as referred to in Articles 87 to 91 of the MDR and Articles 82 to 86 of the IVDR) are fulfilled in respect of the Devices
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Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
CONC PLT & PLS SET W/FILTER	CONC PLT & PLS SET W/FILTER	`999F-E-CC`	`10812747012539`	1	On the market
CONC PLT & PLS SET W/FILTER	CONC PLT & PLS SET W/FILTER	`999F-E`	`10812747012447`	1	On the market
CONNECTOR, SPIKE/MALE LL	CONNECTOR, SPIKE/MALE LL	`00621-00`	`10812747019231`	1	On the market
Plasma Set w/Filter, BMB	Plasma Set w/Filter, BMB	`0792P-SL`	`10812747011587`	1	On the market
Plasma Set, HS Bowl	Plasma Set, HS Bowl	`782HS-P-SL`	`10812747019125`	1	On the market
PLS 2-Bags Closed Set, HS Bowl	PLS 2-Bags Closed Set, HS Bowl	`622HS-00`	`10812747011242`	1	On the market
PLS 3-BAG FFP SET, HS BWL	PLS 3-BAG FFP SET, HS BWL	`623HS-NX`	`10812747019248`	1	On the market
PLS 3-BAG FFP SET, HS BWL	PLS 3-BAG FFP SET, HS BWL	`623HS-NX-CC`	`10812747019323`	1	On the market
PLS 3-Bags Closed Set, HS Bowl	PLS 3-Bags Closed Set, HS Bowl	`623HS-00`	`10812747011266`	1	On the market
PLS 3-BAGS CLOSED SET, HS BOWL	PLS 3-BAGS CLOSED SET, HS BOWL	`623HS-CC`	`10812747019316`	1	On the market
PLS 3-Bags Closed Sets, BMB	PLS 3-Bags Closed Sets, BMB	`0623E-00`	`10812747011198`	1	On the market
PLS Bundled Set w/Air Bag	PLS Bundled Set w/Air Bag	`00782-00`	`10812747019156`	1	On the market
PLS BUNDLED SET W/AIR BAG	PLS BUNDLED SET W/AIR BAG	`00782-CC`	`10812747019286`	1	On the market
PLS BUNDLED SET W/SALINE LINE	PLS BUNDLED SET W/SALINE LINE	`00783-CC`	`10812747019293`	1	On the market
PLS BUNDLED SET W/VAC	PLS BUNDLED SET W/VAC	`00792-CC`	`10812747019798`	1	On the market
PLS Bundled Sets w/Saline Line	PLS Bundled Sets w/Saline Line	`00783-00`	`10812747011785`	1	On the market
PLS Bundled Sets w/Vac	PLS Bundled Sets w/Vac	`00792-00`	`10812747019163`	1	On the market
PLS HARNESS SET	PLS HARNESS SET	`00620‐CC`	`10812747019347`	1	On the market
PLS HARNESS SET	PLS HARNESS SET	`00620-00`	`10812747011754`	1	On the market
PLS HARNESS SET W/DRIP	PLS HARNESS SET W/DRIP	`0620E-CC`	`10812747019309`	1	On the market
PLS HARNESS SET W/DRIP	PLS HARNESS SET W/DRIP	`0620E-00`	`10812747019187`	1	On the market
PLT & PLASMA SET W/FILTERS	PLT & PLASMA SET W/FILTERS	`999FF-P-SL`	`10812747012423`	1	On the market
PLT & PLS SET DOUBLE DOSE	PLT & PLS SET DOUBLE DOSE	`996E2-00`	`10812747012461`	1	On the market
PLT & PLS SET SINGLE DOSE	PLT & PLS SET SINGLE DOSE	`0996E-00`	`10812747012454`	1	On the market
PLT & PLS SET W/FILTER	PLT & PLS SET W/FILTER	`997CF-E`	`10812747012409`	1	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
CONC PLT & PLS SET W/FILTER	CONC PLT & PLS SET W/FILTER	`999F-E-CC`	`10812747012539`	1	On the market
CONC PLT & PLS SET W/FILTER	CONC PLT & PLS SET W/FILTER	`999F-E`	`10812747012447`	1	On the market
CONNECTOR, SPIKE/MALE LL	CONNECTOR, SPIKE/MALE LL	`00621-00`	`10812747019231`	1	On the market
Plasma Set w/Filter, BMB	Plasma Set w/Filter, BMB	`0792P-SL`	`10812747011587`	1	On the market
Plasma Set, HS Bowl	Plasma Set, HS Bowl	`782HS-P-SL`	`10812747019125`	1	On the market
PLS 2-Bags Closed Set, HS Bowl	PLS 2-Bags Closed Set, HS Bowl	`622HS-00`	`10812747011242`	1	On the market
PLS 3-BAG FFP SET, HS BWL	PLS 3-BAG FFP SET, HS BWL	`623HS-NX`	`10812747019248`	1	On the market
PLS 3-BAG FFP SET, HS BWL	PLS 3-BAG FFP SET, HS BWL	`623HS-NX-CC`	`10812747019323`	1	On the market
PLS 3-Bags Closed Set, HS Bowl	PLS 3-Bags Closed Set, HS Bowl	`623HS-00`	`10812747011266`	1	On the market
PLS 3-BAGS CLOSED SET, HS BOWL	PLS 3-BAGS CLOSED SET, HS BOWL	`623HS-CC`	`10812747019316`	1	On the market
PLS 3-Bags Closed Sets, BMB	PLS 3-Bags Closed Sets, BMB	`0623E-00`	`10812747011198`	1	On the market
PLS Bundled Set w/Air Bag	PLS Bundled Set w/Air Bag	`00782-00`	`10812747019156`	1	On the market
PLS BUNDLED SET W/AIR BAG	PLS BUNDLED SET W/AIR BAG	`00782-CC`	`10812747019286`	1	On the market
PLS BUNDLED SET W/SALINE LINE	PLS BUNDLED SET W/SALINE LINE	`00783-CC`	`10812747019293`	1	On the market
PLS BUNDLED SET W/VAC	PLS BUNDLED SET W/VAC	`00792-CC`	`10812747019798`	1	On the market
PLS Bundled Sets w/Saline Line	PLS Bundled Sets w/Saline Line	`00783-00`	`10812747011785`	1	On the market
PLS Bundled Sets w/Vac	PLS Bundled Sets w/Vac	`00792-00`	`10812747019163`	1	On the market
PLS HARNESS SET	PLS HARNESS SET	`00620‐CC`	`10812747019347`	1	On the market
PLS HARNESS SET	PLS HARNESS SET	`00620-00`	`10812747011754`	1	On the market
PLS HARNESS SET W/DRIP	PLS HARNESS SET W/DRIP	`0620E-CC`	`10812747019309`	1	On the market
PLS HARNESS SET W/DRIP	PLS HARNESS SET W/DRIP	`0620E-00`	`10812747019187`	1	On the market
PLT & PLASMA SET W/FILTERS	PLT & PLASMA SET W/FILTERS	`999FF-P-SL`	`10812747012423`	1	On the market
PLT & PLS SET DOUBLE DOSE	PLT & PLS SET DOUBLE DOSE	`996E2-00`	`10812747012461`	1	On the market
PLT & PLS SET SINGLE DOSE	PLT & PLS SET SINGLE DOSE	`0996E-00`	`10812747012454`	1	On the market
PLT & PLS SET W/FILTER	PLT & PLS SET W/FILTER	`997CF-E`	`10812747012409`	1	On the market

Haemonetics S.A.

About HAE SA

Contact details for HAE SA

Competent authority

Officers and regulatory representatives of HAE SA

Related searches

About HAE SA

Contact details for HAE SA

Competent authority

Officers and regulatory representatives of HAE SA

Approved members

Statistics for HAE SA

Certificate health for HAE SA

Related documents

Devices by risk class

Device catalog for HAE SA

Device families (Basic UDI-DI) of HAE SA

Market presence of HAE SA

Connected operators

Importers

Authorised representatives

Related searches

Certificate health for HAE SA

Statistics for HAE SA

Market presence of HAE SA

Devices by risk class

Approved members

Connected operators

Importers

Authorised representatives

Device families (Basic UDI-DI) of HAE SA

Related documents

Device catalog for HAE SA