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Premier Light Support Cotton Retention Bandage
EUDAMEDClass I (EU MDR)
Ref 1970Model 5cmx4m 7cmx4m 7cmx4m 10cmX4m 10cmx4m 15cmx4m 15cmx4m 6cmx4m
Identity
- Trade Name
- PREMIER LIGHT SUPPORT COTTON RETENTION BANDAGE EUDAMED
- Device Name
- Sterile bandage EUDAMED
- Model / Reference
- 5cmx4m 7cmx4m 7cmx4m 10cmX4m 10cmx4m 15cmx4m 15cmx4m 6cmx4m EUDAMED1970 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972403424001 EUDAMED
- Basic UDI-DI
- 697240342SB0000016U EUDAMED
- EMDN Code
- M030402010101 ELASTIC SUPPORT BANDAGES, NON-ADHESIVE, EXTENSIBLE IN ONE DIRECTION, HIGH EXTENSIBILITY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Premier Light Support Cotton Retention Bandage by Henan Zhende Medical Products 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 | 697240342SB0000016U | Class I | Active |
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Manufacturer
- Manufacturer
- Henan Zhende Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000009621
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 9004109c-9b16-4a4a-830f-c2c81a102a14 61 fields · synced Jul 16, 2026