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Oakmed
EUDAMEDClass I (EU MDR)
Ref LPSCA28-4110KVBKRef LPSCA40-0420KRef SCA25-0420KRef AV-4320KRef LPSCA47-4115KVBKRef SCA45-0420KRef AHP5C20Ref SCA35-4120KVRef AHP8C20Ref LPSCA28-0420KRef AV-4120KRef SCA45-4120KVRef SCA35-0420KRef SCA25-4110KVBK
by Oakmed Ltd
Identity
- Trade Name
- Oakmed EUDAMED
- Device Name
- Oakmed Stoma Care and Wound Care products EUDAMED
- Model / Reference
- LPSCA28-4110KVBK EUDAMEDLPSCA40-0420K EUDAMEDSCA25-0420K EUDAMEDAV-4320K EUDAMEDLPSCA47-4115KVBK EUDAMEDSCA45-0420K EUDAMEDAHP5C20 EUDAMEDSCA35-4120KV EUDAMEDAHP8C20 EUDAMEDLPSCA28-0420K EUDAMEDAV-4120K EUDAMEDSCA45-4120KV EUDAMEDSCA35-0420K EUDAMEDSCA25-4110KVBK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060577756620 EUDAMED05060022666344 EUDAMED05060022664760 EUDAMED05060022663169 EUDAMED05060577756606 EUDAMED05060022664876 EUDAMED05060577752455 EUDAMED05060022664319 EUDAMED05060577753728 EUDAMED05060022666320 EUDAMED05060022663077 EUDAMED05060022664395 EUDAMED05060022664791 EUDAMED05060577756569 EUDAMED
- Basic UDI-DI
- 506057775StomaCareR5 EUDAMED506002266StomaCare66 EUDAMED
- EMDN Code
- A1001010202,A1001020202,A1001030202 EUDAMEDA1001010102,A1001020102,A1001030102 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
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
Oakmed by Oakmed 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 | 506057775StomaCareR5 | Class I | Active |
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Manufacturer
- Manufacturer
- Oakmed Ltd
- EUDAMED SRN
- UK-MF-000051482
- Authorised Representative
- Specculo Limited MT-AR-000034988
Sources (14)
- EUDAMED 137ddef1-ebd2-47a7-a980-a02e70f1df12 61 fields · synced Aug 3, 2026
- EUDAMED d39d80a8-086d-458d-bf99-6766ece19c42 61 fields · synced May 16, 2026
- EUDAMED f7086168-5cab-4936-bd7d-d359bc78645e 61 fields · synced May 16, 2026
- EUDAMED c75b5770-b67d-4a28-8f68-862e2c69c187 61 fields · synced May 17, 2026
- EUDAMED 3755882f-c50d-4873-91ca-f5e655358c0c 61 fields · synced May 17, 2026
- EUDAMED 7c75b044-5d40-46c2-ad09-6b7358f41d91 61 fields · synced May 17, 2026
- EUDAMED 0d66f26d-0c47-4ff9-a27d-f996dece2e53 61 fields · synced May 17, 2026
- EUDAMED 6959276d-ae6a-415c-9c14-f7daa95a5bc3 61 fields · synced May 17, 2026
- EUDAMED 069f0c68-9f2f-48dc-b92b-c3b23ff59cad 61 fields · synced May 17, 2026
- EUDAMED f01c5bc6-874b-4639-9314-350515020802 61 fields · synced May 18, 2026
- EUDAMED 38fbc87b-85ec-42ae-a397-ffc29fba2f98 61 fields · synced May 18, 2026
- EUDAMED cc415d29-193f-4233-9e7b-1afd0354c18a 61 fields · synced May 18, 2026
- EUDAMED 0342d7e8-97f1-45fd-9347-8e1c2f16f7ee 61 fields · synced May 19, 2026
- EUDAMED 66aef67d-ab99-42c3-8b9a-22ceda800163 61 fields · synced May 19, 2026