Data from EUDAMED, last updated Jun 11, 2026

Isolation Gown

697588347IsolationGown3A

1 reference

Class I

Data from EUDAMED, last updated Jun 11, 2026

697588347IsolationGown3A

1 reference

Class I

Device family identification

Device name: Isolation Gown
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 →: 697588347IsolationGown3A
Device model: MC121a MC121b reverse wear style MC122a MC122b MC123 suit style MC124a MC124b MC124c MC124d MC124e MC124f coverall style MC125a MC125b MC125c MC125d obverse wear style M/L/XL/XXL
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: Aug 21, 2024

Name: Hospital & Homecare Medical Device Co., Ltd. China
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-000032014
Country: China
Email: sales6@aline-medical.com
Phone: +86 25 84573232

Name: SUNGO 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-000000247
Country: Netherlands

No device characteristics flagged

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

Device family identification

Device name: Isolation Gown
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 →: 697588347IsolationGown3A
Device model: MC121a MC121b reverse wear style MC122a MC122b MC123 suit style MC124a MC124b MC124c MC124d MC124e MC124f coverall style MC125a MC125b MC125c MC125d obverse wear style M/L/XL/XXL
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: Aug 21, 2024

Manufacturer & authorised representative

Name: Hospital & Homecare Medical Device Co., Ltd. China
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-000032014
Country: China
Email: sales6@aline-medical.com
Phone: +86 25 84573232

Name: SUNGO 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-000000247
Country: Netherlands

References

1 reference

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
MC121B	`MC121B`	`06975883470780`	1	On the market