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N77a01-Os01ba-B06

EUDAMED

Class I (EU MDR)

Ref N77A01-OS01BA-B06Model Surgical Face Mask With Tie-On, Surgical Face Mask With Earloop, Children's Surgical Face Mask With Earloop, etcRef N77A01

by Leboo Healthcare Products Limited

Identity

Model / Reference
Surgical Face Mask With Tie-On, Surgical Face Mask With Earloop, Children's Surgical Face Mask With Earloop, etc EUDAMED
N77A01-OS01BA-B06 EUDAMED
N77A01 EUDAMED

Identifiers

Primary DI / UDI-DI
06974424841492 EUDAMED
06974424843779 EUDAMED
06974424841317 EUDAMED
06974424840020 EUDAMED
Basic UDI-DI
697442484L02Q9 EUDAMED
EMDN Code
T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR 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

N77a01-Os01ba-B06 by Leboo Healthcare Products Limited — 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
Leboo Healthcare Products Limited
EUDAMED SRN
CN-MF-000008521
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (4)

  • EUDAMED 777e9ba1-1277-4b45-adaf-94335fc10e56 61 fields · synced Oct 8, 2026
  • EUDAMED fa1cae06-63a1-471a-abba-0f3088d53f9b 61 fields · synced May 17, 2026
  • EUDAMED 4335398e-f6f6-4693-95f1-841b135df787 61 fields · synced May 17, 2026
  • EUDAMED d1dd6a56-9488-49fb-ade5-76b13e975507 61 fields · synced Jun 10, 2026