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Non-elastic Bandage
EUDAMEDClass I (EU MDR)
Ref ENNEB1EA001Ref ENPBX2CA010Ref ENNEB1BA006Ref ENNEB1BA00605Ref ENNEB1DA001Ref ENNEB1BA002Ref ENPBX2CA011Ref ENNEB1BA001Ref ENNEB1CA001Ref ENNEB1CA003
Identity
- Trade Name
- Non-elastic Bandage EUDAMEDElastic Bandage EUDAMED
- Device Name
- Non-elastic Bandage EUDAMEDElastic Bandage EUDAMED
- Model / Reference
- ENNEB1EA001 EUDAMEDENPBX2CA010 EUDAMEDENNEB1BA006 EUDAMEDENNEB1BA00605 EUDAMEDENNEB1DA001 EUDAMEDENNEB1BA002 EUDAMEDENPBX2CA011 EUDAMEDENNEB1BA001 EUDAMEDENNEB1CA001 EUDAMEDENNEB1CA003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974686053978 EUDAMED06974686050274 EUDAMED06974686054791 EUDAMED06974686055026 EUDAMED06974686054739 EUDAMED06974686053596 EUDAMED06974686057150 EUDAMED06974686054678 EUDAMED06974686056764 EUDAMED06974686053992 EUDAMED06974686052803 EUDAMED
- Basic UDI-DI
- 697468605NEB1EA020EH EUDAMED697468605EBX1CA020H9 EUDAMED697468605NEB1BA020DG EUDAMED697468605NEB1DA020E6 EUDAMED697468605NEB1CA020DT EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER EUDAMEDM0303010101 ELASTIC FIXING BANDAGES, NON-ADHESIVE, EXTENSIBLE IN ONE DIRECTION EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Category: Hand/finger splint, reusable
Non-elastic Bandage by Yiwu Ori-Power Medtech Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hand/finger splint, reusable.
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- ORTHOSIS FRACTURE WRIST-HAND PLASTICAST — AliMed, LLC · Class I
- MedTextile — Medtex Swiss Ltd · Class I
- PERFORMANCE HEALTH — Asp Global, LLC · Class I
- McKie Thumb Splint Pediatric — McKie Splints, LLC · Class I
- Plastalume — BROWNMED, INC. · Class I
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 | 697468605NEB1EA020EH | 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 (11)
- EUDAMED 40ee42d7-7c28-4f65-b683-e5dea3f0adbd 61 fields · synced Sep 18, 2026
- EUDAMED f7259e13-39de-417a-ae39-51ffc4e65ac6 61 fields · synced May 17, 2026
- EUDAMED cd3c637f-2e76-4511-92d0-e4ea6d3fb2de 61 fields · synced May 17, 2026
- EUDAMED 3d29581d-c432-4514-9ed8-4859b64a89d5 61 fields · synced May 17, 2026
- EUDAMED 166d6f42-8b0c-459b-81e2-41e41191f54d 61 fields · synced May 18, 2026
- EUDAMED 8cdbb224-a517-4605-9326-a888568880d9 61 fields · synced May 18, 2026
- EUDAMED 91dff17c-df6d-4412-9baf-749eeae70adb 61 fields · synced May 18, 2026
- EUDAMED caf91138-7176-4f00-9870-7f686e962079 61 fields · synced May 18, 2026
- EUDAMED 73311163-511e-4fb9-b008-58d9510fcefd 61 fields · synced May 18, 2026
- EUDAMED 2f23053e-d605-4d97-8c0d-be09ce3b36d7 61 fields · synced May 19, 2026
- EUDAMED 7c110f4b-234b-42f2-843c-2afd1652816e 61 fields · synced May 19, 2026