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Self-adhesive elastic bandage
EUDAMEDClass I (EU MDR)
Ref EB01K01Model EB01K01, EB01K02, EB01K03
Identity
- Device Name
- Self-adhesive elastic bandage EUDAMED
- Model / Reference
- EB01K01, EB01K02, EB01K03 EUDAMEDEB01K01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976800672454 EUDAMED
- Basic UDI-DI
- 697680067elasticbandageCV EUDAMED
- EMDN Code
- M0303010201 ELASTIC FIXING BANDAGES, SELF-ADHESIVE, EXTENSIBLE IN ONE DIRECTION EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- 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
Self-adhesive elastic bandage by Sinopharm Fortune International Trading Corp. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697680067elasticbandageCV | Class I | Active |
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Manufacturer
- Manufacturer
- Sinopharm Fortune International Trading Corp.
- EUDAMED SRN
- CN-MF-000038309
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED becb9b84-21ae-4040-9930-571bf94378e1 61 fields · synced Jul 15, 2026