Data from EUDAMED, last updated Jun 11, 2026

Reusable Headgear

69239801NR1EARP

2 references

Class I

Data from EUDAMED, last updated Jun 11, 2026

69239801NR1EARP

2 references

Class I

Device family identification

Device name: Reusable Headgear
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: 69239801NR1EARP
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1
Version date: Feb 6, 2026

Name: GaleMed (Xiamen) Co., Ltd.
SRN An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor. View in glossary →: CN-MF-000020627
Country: China
Email: xm_qa@galemed.com

Name: Emergo Europe B.V.
SRN An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor. View in glossary →: NL-AR-000000116
Country: Netherlands
Phone: +31 70 345 8570

No device characteristics flagged

European Medical Device Nomenclature — the EU product classifications carried across this device family's references.

Device family identification

Device name: Reusable Headgear
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: 69239801NR1EARP
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1
Version date: Feb 6, 2026

Manufacturer & authorised representative

Name: GaleMed (Xiamen) Co., Ltd.
SRN An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor. View in glossary →: CN-MF-000020627
Country: China
Email: xm_qa@galemed.com

Name: Emergo Europe B.V.
SRN An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor. View in glossary →: NL-AR-000000116
Country: Netherlands
Phone: +31 70 345 8570

References

2 references

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
Headgear for CPAP Mask, L, Silicone	`AM0014`	`06923980102202`	1	On the market
Silicone Head Harness Large	`XTA0001`	`06923980111570`	1	On the market