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Medicare
EUDAMEDClass I (EU MDR)
Ref MD219RCRef MD81Ref MD80Ref MD218RCRef MD11Ref MD548Ref MD09Ref MD1801Ref MD08Ref MD74Ref MD75Ref MD217RCRef GMD0002Ref MD02/1Ref MD05/1Ref MD1913Ref MD536Ref MD220Ref MD061Ref MD212Ref MD17Ref MD01/1Ref MD208Ref MD03/1Ref MD207Ref MD04/1Ref MD214RCRef MD1809Ref MD76Ref MD79Ref MD78Ref MD73Ref GMD0045
Identity
- Trade Name
- Medicare EUDAMED
- Device Name
- Plaster EUDAMEDAbsorbent Cotton Wools EUDAMEDAir Activated 8 Hour Heat Patch EUDAMEDBurn Dressing EUDAMEDPulse Oximeters EUDAMEDSports Therapy EUDAMEDT2 Thermometer EUDAMEDA4-Blood Pressure Monitor Wireless EUDAMEDBurn Gel Spray EUDAMEDBurn Spray Gel EUDAMED
- Model / Reference
- MD219RC EUDAMEDMD81 EUDAMEDMD80 EUDAMEDMD218RC EUDAMEDMD11 EUDAMEDMD548 EUDAMEDMD09 EUDAMEDMD1801 EUDAMEDMD08 EUDAMEDMD74 EUDAMEDMD75 EUDAMEDMD217RC EUDAMEDGMD0002 EUDAMEDMD02/1 EUDAMEDMD05/1 EUDAMEDMD1913 EUDAMEDMD536 EUDAMEDMD220 EUDAMEDMD061 EUDAMEDMD212 EUDAMEDMD17 EUDAMEDMD01/1 EUDAMEDMD208 EUDAMEDMD03/1 EUDAMEDMD207 EUDAMEDMD04/1 EUDAMEDMD214RC EUDAMEDMD1809 EUDAMEDMD76 EUDAMEDMD79 EUDAMEDMD78 EUDAMEDMD73 EUDAMEDGMD0045 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14897122904773 EUDAMED14897122905510 EUDAMED14897122905503 EUDAMED14897122904766 EUDAMED14897122904711 EUDAMED04897122901416 EUDAMED14897122904674 EUDAMED14897122904308 EUDAMED14897122904704 EUDAMED14897122903424 EUDAMED04897122903434 EUDAMED14897122904292 EUDAMED24897122904527 EUDAMED14897122904216 EUDAMED14897122904247 EUDAMED04897122901515 EUDAMED14897122905565 EUDAMED14897122904322 EUDAMED04897122901317 EUDAMED14897122904698 EUDAMED14897122904728 EUDAMED14897122904209 EUDAMED14897122904759 EUDAMED14897122904223 EUDAMED14897122904667 EUDAMED14897122904230 EUDAMED14897122904285 EUDAMED04897122901027 EUDAMED04897122903441 EUDAMED04897122903472 EUDAMED04897122903465 EUDAMED04897122903410 EUDAMED14897122904544 EUDAMED
- Basic UDI-DI
- 489712290plasterK7 EUDAMED489712290abcowool5D EUDAMEDB-04897122901416 EUDAMEDB-14897122903424 EUDAMEDB-04897122903434 EUDAMEDB-04897122901515 EUDAMED489712290Progear6R EUDAMEDB-04897122901317 EUDAMEDB-04897122901027 EUDAMEDB-04897122903441 EUDAMEDB-04897122903472 EUDAMEDB-04897122903465 EUDAMEDB-04897122903410 EUDAMED
- Unit of Use DI
- 04897122904776 EUDAMED04897122904677 EUDAMED04897122904301 EUDAMED04897122904707 EUDAMED14897122904520 EUDAMED04897122904219 EUDAMED04897122904240 EUDAMED04897122904721 EUDAMED04897122904752 EUDAMED04897122904226 EUDAMED04897122904660 EUDAMED04897122904233 EUDAMED
- EMDN Code
- M03030202 SKIN PROTECTIVE BANDAGES EUDAMEDM010101 HYDROPHILIC COTTON EUDAMEDZ120602 PHYSIOTHERAPY EQUIPMENT EUDAMEDM04040502 HYDROGEL DRESSINGS, COMBINED WITH OTHER SUBSTANCES EUDAMEDZ1203020302,Z1203020408 EUDAMEDY060403 ABDOMINAL MUSCLES SUPPORTS EUDAMEDV0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMEDZ1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMEDClass IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
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
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Medicare by Fleming Medical Ltd. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 489712290plasterK7 | Class I | Active |
| EUDAMED | European Union | CE/MDD | 489712290plasterK7 | Class I | Active |
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Manufacturer
- Manufacturer
- Fleming Medical Ltd.
- EUDAMED SRN
- CN-MF-000014750
- Authorised Representative
- Fleming Medical IE-AR-000012571
Sources (33)
- EUDAMED 82db58e5-b78a-484a-ab49-16bc97f2ac42 61 fields · synced Sep 18, 2026
- EUDAMED dc3a978a-5cc2-47ae-aa0f-2db3ceff6d3f 61 fields · synced May 11, 2026
- EUDAMED f6a5e48c-192c-457c-8713-d18236cd6302 61 fields · synced May 11, 2026
- EUDAMED 17a1864e-cb9f-41df-8c51-fd01088b28cd 61 fields · synced May 11, 2026
- EUDAMED cdd29a33-ba9b-42e0-9f1d-4ae430132130 61 fields · synced May 16, 2026
- EUDAMED c950e75d-2967-415b-9f34-6436d737f861 61 fields · synced May 16, 2026
- EUDAMED 20907a4b-d7ea-43e7-a5be-5515dec93b65 61 fields · synced May 16, 2026
- EUDAMED 9bc6a806-ba54-4334-accc-c6d3fb4081d3 61 fields · synced May 16, 2026
- EUDAMED 3a7ea4bb-37fa-43cf-bb70-c4d1f15f1aae 61 fields · synced May 16, 2026
- EUDAMED 69341170-2265-444c-9ea1-c316eb59ce91 61 fields · synced May 16, 2026
- EUDAMED 72ada67a-0f64-4f37-a439-94ddd31ac6a0 61 fields · synced May 16, 2026
- EUDAMED 892d092a-0168-4420-88e6-4a671b1889d3 61 fields · synced May 17, 2026
- EUDAMED 6ace65b9-0262-4ab1-9e6a-f7a8d0a29ed0 61 fields · synced May 17, 2026
- EUDAMED f43b8203-db35-44d4-8aec-4dbe6d32273b 61 fields · synced May 17, 2026
- EUDAMED b796394d-1f61-47cd-b297-3a18a3f2ac1f 61 fields · synced May 17, 2026
- EUDAMED cdce67e8-1f42-40f2-bc80-f1f9f187c376 61 fields · synced May 17, 2026
- EUDAMED f31ba17e-ba48-4bf5-a20f-3731a2cab053 61 fields · synced May 17, 2026
- EUDAMED b89eca98-0ead-41ae-bec0-9c5a2cd864d5 61 fields · synced May 17, 2026
- EUDAMED c0a6eb58-8857-44b5-a103-caf06c186f1f 61 fields · synced May 17, 2026
- EUDAMED 7fe54315-edd0-482e-80fa-14ae67180c09 61 fields · synced May 18, 2026
- EUDAMED 5be9fe3b-100d-467d-a536-cf41ebd1d627 61 fields · synced May 18, 2026
- EUDAMED c553269d-1f0f-4593-a669-037f0198fe14 61 fields · synced May 18, 2026
- EUDAMED 5507b3e3-92ca-461c-9e03-9d70aab337ba 61 fields · synced May 18, 2026
- EUDAMED 2d67ce05-ab7f-4be3-91aa-33f4ce525a69 61 fields · synced May 18, 2026
- EUDAMED e9797a0b-81e5-40d6-b6d7-c795fda57cb8 61 fields · synced May 18, 2026
- EUDAMED 17fed1ff-8c63-4767-aac1-37dcfc5f55c3 61 fields · synced May 18, 2026
- EUDAMED 9c816960-a30b-403d-8d6f-0951786bef2b 61 fields · synced May 18, 2026
- EUDAMED a1cbfe42-ffcf-4b5e-a31a-ea48a53b1e3d 61 fields · synced May 18, 2026
- EUDAMED e0ad3f99-8271-4c31-b308-9b173b62e64f 61 fields · synced May 18, 2026
- EUDAMED 035992d0-76de-46a4-ad2a-1c4b1e361fcd 61 fields · synced May 18, 2026
- EUDAMED 91410848-1c9d-4e04-b519-f055817de0de 61 fields · synced May 18, 2026
- EUDAMED 24eb6555-074d-4652-b1f9-1bca155232a3 61 fields · synced May 18, 2026
- EUDAMED 806af906-803e-427e-ac96-07cdf85df612 61 fields · synced May 19, 2026