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Bandage

EUDAMED

Class I (EU MDR)

Ref PBT bandageModel PBT bandage, spandex bandage, self-adhesive bandage, sports bandage, polymer bandage, high elasticity bandage, cotton bandage, gauze bandageRef 5cm*1mModel 5cm*1m~20m, 7.5cm*1m~20m, 10cm*1m~20m, 15cm*1m~20m, 20cm*1m~20m, or Customized

by Yiwu City Ange Medical Instrument CO., LTD

Identity

Trade Name
Bandage EUDAMED
Plaster of paris bandage EUDAMED
Device Name
Bandage EUDAMED
Plaster of paris bandage EUDAMED
Model / Reference
PBT bandage, spandex bandage, self-adhesive bandage, sports bandage, polymer bandage, high elasticity bandage, cotton bandage, gauze bandage EUDAMED
PBT bandage EUDAMED
5cm*1m~20m, 7.5cm*1m~20m, 10cm*1m~20m, 15cm*1m~20m, 20cm*1m~20m, or Customized EUDAMED
5cm*1m EUDAMED

Identifiers

Primary DI / UDI-DI
06978841800001 EUDAMED
06978841800506 EUDAMED
Basic UDI-DI
697884180Bandage01HX EUDAMED
697884180Ppbandage01XA EUDAMED
EMDN Code
M0303010101 ELASTIC FIXING BANDAGES, NON-ADHESIVE, EXTENSIBLE IN ONE DIRECTION EUDAMED
M03050201 NATURAL CAST BANDAGES AND SPLINTS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Belgium EUDAMED
Austria 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 Yiwu City Ange 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

EUDAMED SRN
CN-MF-000048646
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (2)

  • EUDAMED 3cbe8e63-6773-4c1f-9b7b-322ba4599b4f 61 fields · synced Oct 6, 2026
  • EUDAMED c172fdd9-34d8-408b-b251-6f17a430380b 61 fields · synced May 19, 2026