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Film adhésif stérile transparent
EUDAMEDClass I (EU MDR)
Ref FA1520/ALV5594Ref FAC0910/ALV5596Ref FAC0915/ALV5597Ref FAC0507/ALV5595
Identity
- Trade Name
- Film adhésif stérile transparent EUDAMEDFilm adhésif stérile transparent avec compresse centrale EUDAMED
- Device Name
- Sterile Adhesive Surgical Dressing EUDAMED
- Model / Reference
- FA1520/ALV5594 EUDAMEDFAC0910/ALV5596 EUDAMEDFAC0915/ALV5597 EUDAMEDFAC0507/ALV5595 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03664666016668 EUDAMED03664666016699 EUDAMED03664666016675 EUDAMED03664666016705 EUDAMED
- Basic UDI-DI
- 69593857SASD0000013M EUDAMED
- EMDN Code
- M04010102 POLYURETHANE (OR OTHER MATERIAL) ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
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
Film adhésif stérile transparent by Zhende Medical 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 | 69593857SASD0000013M | Class I | Active |
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Manufacturer
- Manufacturer
- Zhende Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000009961
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (4)
- EUDAMED c438d025-a23d-4599-bb27-be1e933937c2 61 fields · synced Jul 19, 2026
- EUDAMED c7d0837b-4cd2-4538-a58e-9ea67a783085 61 fields · synced May 16, 2026
- EUDAMED f1a84f8c-d0eb-424c-a6d4-c987f406dfc7 61 fields · synced May 17, 2026
- EUDAMED b1c7cb40-2cdd-4d7c-a791-6a8095cc17f7 61 fields · synced May 18, 2026