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Disposable Pressure Bandages

EUDAMED

Class I (EU MDR)

Ref OM-TB03-03Ref OM-TB03-01Ref OM-TB03-02Ref OM-TB04-01

by Ortus Medi-Tech Co., Ltd

Identity

Trade Name
Disposable Pressure Bandages EUDAMED
Device Name
Disposable Pressure Bandages EUDAMED
Model / Reference
OM-TB03-03 EUDAMED
OM-TB03-01 EUDAMED
OM-TB03-02 EUDAMED
OM-TB04-01 EUDAMED

Identifiers

Primary DI / UDI-DI
06972985350460 EUDAMED
06972985350446 EUDAMED
06972985350453 EUDAMED
06972985350477 EUDAMED
Basic UDI-DI
B-06972985350460 EUDAMED
B-06972985350446 EUDAMED
B-06972985350453 EUDAMED
B-06972985350477 EUDAMED
EMDN Code
M0399 BANDAGES - OTHER (see Y06 for collars, tutors, etc.) EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Italy EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Disposable Pressure Bandages by Ortus Medi-Tech Co., Ltd — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Ortus Medi-Tech Co., Ltd
EUDAMED SRN
CN-MF-000031033
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (4)

  • EUDAMED 2c0649b7-b4b6-44a0-979e-7a462dc4c001 61 fields · synced Jul 26, 2026
  • EUDAMED 4ddf00b8-b72b-47b2-b999-270851cd3cdf 61 fields · synced May 17, 2026
  • EUDAMED 5c6497ea-7bc2-466b-af7e-6bda041f5caa 61 fields · synced May 18, 2026
  • EUDAMED 2c7adf09-eb66-4975-881c-a6d29069fca9 61 fields · synced May 18, 2026