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sanity

EUDAMED

Class I (EU MDR)

Ref 410021060Model DL-F-I/C/L, DL-FB-I/C/L, DL-FP-I/C/L, DL-FF-I/C/L, DL-FFP-I/C/L, DL-R-I/C/L, DL-RC-I/C/L/II/D/H/CC, DL-RP-I/C/L, DL-U-S/M/L, DL-UP-S/M/L, DL-DP-S/M/L, DL-OR-S/M/L, DL-DR-S/M/L, DL-OP-S/M/L

by Taian Dalu Medical Instrument Co., Ltd.

Identity

Trade Name
sanity EUDAMED
Device Name
Face Masks EUDAMED
Model / Reference
DL-F-I/C/L, DL-FB-I/C/L, DL-FP-I/C/L, DL-FF-I/C/L, DL-FFP-I/C/L, DL-R-I/C/L, DL-RC-I/C/L/II/D/H/CC, DL-RP-I/C/L, DL-U-S/M/L, DL-UP-S/M/L, DL-DP-S/M/L, DL-OR-S/M/L, DL-DR-S/M/L, DL-OP-S/M/L EUDAMED
410021060 EUDAMED

Identifiers

Primary DI / UDI-DI
16970701960105 EUDAMED
Basic UDI-DI
697070196410021018KM EUDAMED
EMDN Code
R03010301 AEROSOL THERAPY MASKS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Netherlands 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

sanity by Taian Dalu Medical Instrument Co., Ltd. — Class I — 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
Taian Dalu Medical Instrument Co., Ltd.
EUDAMED SRN
CN-MF-000003009
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (1)

  • EUDAMED 0d19977f-ca93-4b64-8816-fd8926b4d480 61 fields · synced Jun 18, 2026