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4bl
EUDAMEDClass I (EU MDR)
Ref 4BL-NS-PF-55-SModel Plastic / Flexible Fabric / PU / Cotton / Non-woven（eye patch） / Bamboo
Identity
- Trade Name
- 4BL EUDAMED
- Device Name
- Adhesive Bandage EUDAMED
- Model / Reference
- Plastic / Flexible Fabric / PU / Cotton / Non-woven（eye patch） / Bamboo EUDAMED4BL-NS-PF-55-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974700816015 EUDAMED
- Basic UDI-DI
- 697470081adhesiveband5F EUDAMED
- EMDN Code
- M040701 NASAL PADS 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
4bl 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 (1)
- EUDAMED d043a5ab-5fa2-45ed-994b-8c0c70519a3a 61 fields · synced Oct 6, 2026