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Bandage

EUDAMED

Class I (EU MDR)

Ref M07-B001Ref M07-B002-08Ref M07-B006-08Ref M07-B003-08Ref M07-B004

by Orantech Inc.

Identity

Trade Name
Bandage EUDAMED
Device Name
Bandage EUDAMED
Model / Reference
M07-B001 EUDAMED
M07-B002-08 EUDAMED
M07-B006-08 EUDAMED
M07-B003-08 EUDAMED
M07-B004 EUDAMED

Identifiers

Primary DI / UDI-DI
06941691977193 EUDAMED
06941691977216 EUDAMED
06941691977278 EUDAMED
06941691977254 EUDAMED
06941691977247 EUDAMED
Basic UDI-DI
69416919ORANTECH22QX EUDAMED
EMDN Code
M0303010103 ELASTIC FIXING BANDAGES, NON-ADHESIVE, EXTENSIBLE IN TWO DIRECTIONS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Denmark 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

Bandage by Orantech Inc. — 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
Orantech Inc.
EUDAMED SRN
CN-MF-000013859
Authorised Representative
Medten EU ApS DK-AR-000034434

Sources (5)

  • EUDAMED a53ef622-a9dc-4806-87aa-38566f2512e1 61 fields · synced Aug 3, 2026
  • EUDAMED 346a7300-8493-49ff-b5c7-08de2bae667a 61 fields · synced May 18, 2026
  • EUDAMED 044e06af-4ed3-4885-ba44-16c8aee56929 61 fields · synced May 18, 2026
  • EUDAMED e8e40394-50d0-42cb-b92b-72784deb4fb1 61 fields · synced May 19, 2026
  • EUDAMED e193cc9d-03e4-4251-b4a8-c6761207b885 61 fields · synced May 19, 2026