Identity
- Trade Name
- PBT Bandage EUDAMED
- Device Name
- PBT Bandage EUDAMED
- Model / Reference
- ENPBX1AA010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942509230097 EUDAMED
- Basic UDI-DI
- 697468605PBX1AA020QG EUDAMED
- EMDN Code
- M03030199 ELASTIC FIXING BANDAGES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
PBT Bandage by Yiwu Ori-Power Medtech 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697468605PBX1AA020QG | Class I | Active |
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Manufacturer
- Manufacturer
- Yiwu Ori-Power Medtech Co., Ltd.
- EUDAMED SRN
- CN-MF-000021146
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED b8e03a14-63ea-4270-977d-d5a5b1a803dc 61 fields · synced Jul 23, 2026