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Aposan
EUDAMEDClass I (EU MDR)
Ref NE0113Model Plastic / Flexible Fabric / PU / Cotton / Non-woven（eye patch） / BambooRef NE0114
Identity
- Trade Name
- APOSAN EUDAMED
- Device Name
- Adhesive Bandage EUDAMED
- Model / Reference
- Plastic / Flexible Fabric / PU / Cotton / Non-woven（eye patch） / Bamboo EUDAMEDNE0113 EUDAMEDNE0114 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974700814011 EUDAMED06974700814028 EUDAMED
- Basic UDI-DI
- 697470081adhesiveband5F EUDAMED
- EMDN Code
- M040303 ORTHOPTIC EYE PATCHES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Aposan by Changzhou Recoo Healthcare 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 | 697470081adhesiveband5F | Class I | Active |
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Manufacturer
- Manufacturer
- Changzhou Recoo Healthcare Co., Ltd.
- EUDAMED SRN
- CN-MF-000011593
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (2)
- EUDAMED dcef4779-6db0-4ee1-8891-c63e4819a88e 61 fields · synced Oct 6, 2026
- EUDAMED 35858153-ae4b-4ed1-8a36-7ac21bd0df7e 61 fields · synced May 17, 2026