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Face Mask

EUDAMED

Class I (EU MDR)

Ref LEVEL 3Model Type I;Type II;Type IIR;LEVEL 1;LEVEL 2;LEVEL 3

by Hubei Guarddent Medical Technology Co., Ltd

Identity

Trade Name
FACE MASK EUDAMED
Device Name
FACE MASK EUDAMED
Model / Reference
Type I;Type II;Type IIR;LEVEL 1;LEVEL 2;LEVEL 3 EUDAMED
LEVEL 3 EUDAMED

Identifiers

Primary DI / UDI-DI
06978502824926 EUDAMED
06978502824971 EUDAMED
06978502824919 EUDAMED
06978502824902 EUDAMED
06978502824964 EUDAMED
Basic UDI-DI
697565200FM001CT EUDAMED
EMDN Code
Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Face Mask by Hubei Guarddent Medical Technology Co., Ltd — Class I — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Hubei Guarddent Medical Technology Co., Ltd
EUDAMED SRN
CN-MF-000028116
Authorised Representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Sources (5)

  • EUDAMED 84a0a90a-c1b9-4d2e-9404-82252c25da4e 61 fields · synced Oct 7, 2026
  • EUDAMED b874ff6b-fdcb-45f4-bad0-1d39844f3d3a 61 fields · synced May 16, 2026
  • EUDAMED 9a75a68c-774a-470f-a44c-446c0d8fc2d7 61 fields · synced May 17, 2026
  • EUDAMED 54a30d5b-cced-4948-b804-fa70f13c4baa 61 fields · synced May 19, 2026
  • EUDAMED c9ebed36-fa66-4405-80a8-a2426a933af1 61 fields · synced May 19, 2026