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Sterile Bandage
EUDAMEDClass I (EU MDR)
Ref FA200-9069Model Type A,Type BRef FA200-9050Ref FA200-9046Ref FA200-9075Ref FA200-9052Ref FA200-9057Ref FA200-9060Ref FA200-9049Ref FA200-9054Ref FA200-9055Ref FA200-9047Ref FA200-9065Ref FA200-9051Ref FA200-9063Ref FA200-9064Ref FA200-9066Ref FA200-9059Ref FA200-9076Ref FA200-9071Ref FA200-9073Ref M03040201Ref FA200-9068
Identity
- Trade Name
- Sterile Bandage EUDAMED
- Device Name
- Sterile Bandage EUDAMED
- Model / Reference
- Type A,Type B EUDAMEDFA200-9069 EUDAMEDFA200-9050 EUDAMEDFA200-9046 EUDAMEDFA200-9075 EUDAMEDFA200-9052 EUDAMEDFA200-9057 EUDAMEDFA200-9060 EUDAMEDFA200-9049 EUDAMEDFA200-9054 EUDAMEDFA200-9055 EUDAMEDFA200-9047 EUDAMEDFA200-9065 EUDAMEDFA200-9051 EUDAMEDFA200-9063 EUDAMEDFA200-9064 EUDAMEDFA200-9066 EUDAMEDFA200-9059 EUDAMEDFA200-9076 EUDAMEDFA200-9071 EUDAMEDFA200-9073 EUDAMEDM03040201 EUDAMEDFA200-9068 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922820990696 EUDAMED06922820990504 EUDAMED06922820990467 EUDAMED06922820990757 EUDAMED06922820990528 EUDAMED06922820990573 EUDAMED06922820990603 EUDAMED06922820990498 EUDAMED06922820990542 EUDAMED06922820990559 EUDAMED06922820990474 EUDAMED06922820990658 EUDAMED06922820990511 EUDAMED06922820990634 EUDAMED06922820990641 EUDAMED06922820990665 EUDAMED06922820990597 EUDAMED06922820990764 EUDAMED06922820990719 EUDAMED06922820990733 EUDAMED06922820990610 EUDAMED06922820990689 EUDAMED
- Basic UDI-DI
- 69228209MDN1204IS0000347N EUDAMED
- EMDN Code
- M0304010101,M0304010102,M0304010103 EUDAMEDM030402010101 ELASTIC SUPPORT BANDAGES, NON-ADHESIVE, EXTENSIBLE IN ONE DIRECTION, HIGH EXTENSIBILITY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
Sterile Bandage by RFX+CARE Manufacturing 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 | 69228209MDN1204IS0000347N | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- RFX+CARE Manufacturing Co., Ltd.
- EUDAMED SRN
- CN-MF-000002971
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (22)
- EUDAMED bc4e5673-9881-4668-bcac-907ff48feb27 61 fields · synced Oct 5, 2026
- EUDAMED 5667dda2-fd4b-422a-8ea1-f931afa932ef 61 fields · synced May 16, 2026
- EUDAMED d09d7bef-ea31-4a97-bb9d-055a2edb7e98 61 fields · synced May 16, 2026
- EUDAMED 2946d21f-be12-4651-b11d-25e31006419e 61 fields · synced May 17, 2026
- EUDAMED bc723925-1217-4403-ae8e-2a7093967a50 61 fields · synced May 17, 2026
- EUDAMED cf15b4b1-562e-418c-8e48-7d040b3a2e55 61 fields · synced May 17, 2026
- EUDAMED c0837a94-3cf5-4722-ace2-796b701f7618 61 fields · synced May 17, 2026
- EUDAMED 545ecc2c-cb97-49c5-82fa-5b55a816938c 61 fields · synced May 18, 2026
- EUDAMED b8f215d6-b133-4a8b-827f-bc79887c35d9 61 fields · synced May 18, 2026
- EUDAMED b5f5c3f2-3b32-4549-9797-366d0618e9bf 61 fields · synced May 18, 2026
- EUDAMED fd4c15d8-5294-4995-bfad-f2e93a8cb0bb 61 fields · synced May 18, 2026
- EUDAMED 8cba4de1-d361-4633-9de5-bd9ea4fd9111 61 fields · synced May 18, 2026
- EUDAMED 0e872d38-ac91-48f2-89fb-30426adbe7f9 61 fields · synced May 18, 2026
- EUDAMED c8242280-88b0-438e-bfa1-ceb3a907ed4b 61 fields · synced May 18, 2026
- EUDAMED 4b695ca1-5bb3-4fd8-a518-971439f24474 61 fields · synced May 18, 2026
- EUDAMED 3644a74f-6d06-4b41-bebb-617da51af714 61 fields · synced May 18, 2026
- EUDAMED eb3084d6-beb2-4aa4-aa8c-502b11ae3494 61 fields · synced May 18, 2026
- EUDAMED 2282c7be-ab05-444e-bc2a-d835c34009e7 61 fields · synced May 18, 2026
- EUDAMED b9cba452-f393-4286-8bb7-ec38748603e9 61 fields · synced May 18, 2026
- EUDAMED 915572d9-c2ef-4102-a528-b14c403c11d3 61 fields · synced May 18, 2026
- EUDAMED 0ae4b1ca-9638-449c-8e52-2d4855686b47 61 fields · synced May 19, 2026
- EUDAMED 2aafad98-524d-4e1f-b286-e3c81d0339ec 61 fields · synced May 19, 2026