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POP Bandage
EUDAMEDClass I (EU MDR)
Ref 5cm x 2.7mModel 5cm x2.7m, 5cm x 3m, 7.5cm x2.7m, 7.5cm x 3m, 8cm x2.7m, 8cmx3m, 10cm x2.7m, 10cm x 3m, 12cm x2.7m, 12cmx3m, 15cm x2.7m, 15cm x 3m, 20cm x2.7m, 20cm x 3m
Identity
- Device Name
- POP Bandage EUDAMED
- Model / Reference
- 5cm x2.7m, 5cm x 3m, 7.5cm x2.7m, 7.5cm x 3m, 8cm x2.7m, 8cmx3m, 10cm x2.7m, 10cm x 3m, 12cm x2.7m, 12cmx3m, 15cm x2.7m, 15cm x 3m, 20cm x2.7m, 20cm x 3m EUDAMED5cm x 2.7m EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974700813502 EUDAMED
- Basic UDI-DI
- 697470081POPbandage8B EUDAMED
- EMDN Code
- M03050202 SYNTHETIC CAST BANDAGES AND SPLINTS 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
Category: Cotton wool roll, sterile
POP Bandage by Changzhou Recoo Healthcare Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697470081POPbandage8B | 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 c1f4d1c3-d28c-41ae-80f6-aefcd11d184d 61 fields · synced Jul 11, 2026