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Blister plaster
EUDAMEDClass I (EU MDR)
Ref FA200-9117Model 3.7x5.5cmRef FA200-9108Ref FA200-9106Ref FA200-9126Ref FA200-9098Ref FA200-9101Ref FA200-9111Ref FA200-9125Ref FA200-9107Ref FA200-9116Ref FA200-9114Ref FA200-9099Ref FA200-9110
Identity
- Trade Name
- Blister plaster EUDAMED
- Device Name
- Sterile Blister Plaster EUDAMED
- Model / Reference
- 3.7x5.5cm EUDAMEDFA200-9117 EUDAMEDFA200-9108 EUDAMEDFA200-9106 EUDAMEDFA200-9126 EUDAMEDFA200-9098 EUDAMEDFA200-9101 EUDAMEDFA200-9111 EUDAMEDFA200-9125 EUDAMEDFA200-9107 EUDAMEDFA200-9116 EUDAMEDFA200-9114 EUDAMEDFA200-9099 EUDAMEDFA200-9110 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922820991174 EUDAMED06922820991082 EUDAMED06922820991068 EUDAMED06922820991266 EUDAMED06922820990986 EUDAMED06922820991013 EUDAMED06922820991112 EUDAMED06922820991259 EUDAMED06922820991075 EUDAMED06922820991167 EUDAMED06922820991143 EUDAMED06922820990993 EUDAMED06922820991105 EUDAMED
- Basic UDI-DI
- 69228209MDN1204IS0000367S EUDAMED
- EMDN Code
- M04040301 HYDROCOLLOID DRESSINGS, NON-COMBINED 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
Blister plaster 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 | 69228209MDN1204IS0000367S | Class I | Active |
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Manufacturer
- Manufacturer
- RFX+CARE Manufacturing Co., Ltd.
- EUDAMED SRN
- CN-MF-000002971
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (13)
- EUDAMED e704ba1a-6748-4c58-9c82-59ecdd0ac662 61 fields · synced Jul 27, 2026
- EUDAMED baa3554a-0df8-4c32-b59d-4bc45a061f89 61 fields · synced May 17, 2026
- EUDAMED df7d8652-0269-4fa4-9eeb-fab16cbb8ea5 61 fields · synced May 17, 2026
- EUDAMED 3a469750-b48e-479e-8dac-51694cd04a2d 61 fields · synced May 17, 2026
- EUDAMED 54d04b4a-dfda-4eb2-8b95-997c518eb397 61 fields · synced May 17, 2026
- EUDAMED c645aa22-82b2-48e4-a295-1072cb45c9e9 61 fields · synced May 17, 2026
- EUDAMED cec1aeea-590a-4d5a-97c3-a34219553a6d 61 fields · synced May 17, 2026
- EUDAMED 3d7cb9cc-9578-405e-b67b-2357e2330ffe 61 fields · synced May 17, 2026
- EUDAMED 5c78da7d-a3df-4f6b-a7ad-77cb3c2b64a1 61 fields · synced May 17, 2026
- EUDAMED df12fe44-e734-41be-b43f-da6e977aed83 61 fields · synced May 17, 2026
- EUDAMED 9d1064d1-8786-4569-82dc-9e7495d57c79 61 fields · synced May 18, 2026
- EUDAMED dc891e69-bb03-4885-b87b-5ecc0a767707 61 fields · synced May 18, 2026
- EUDAMED d4e334e1-ae8a-44f8-b544-fc2f46e7978f 61 fields · synced May 19, 2026