Identity
- Trade Name
- Malleable Probe EUDAMED
- Device Name
- Malleable Probe EUDAMEDProbes EUDAMED
- Model / Reference
- 202-3026 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060267132925 EUDAMED05060267132680 EUDAMED05060267131522 EUDAMED05060267133267 EUDAMED
- Basic UDI-DI
- B-05060267132925 EUDAMEDB-05060267132680 EUDAMEDB-05060267131522 EUDAMED506026713Probes00000000VW EUDAMED
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMEDNorway EUDAMEDItaly EUDAMEDSpain 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
Category: Joint prosthesis implantation kit, single-use
Malleable Probe by Xiros Limited — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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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 | B-05060267132925 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-05060267132925 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Xiros Limited
- EUDAMED SRN
- GB-MF-000004396
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (4)
- EUDAMED 8a863d44-3e5d-46ba-84c5-e6d01f0e5c09 61 fields · synced Jul 30, 2026
- EUDAMED 3e09810b-00c4-4fa8-aafb-5c35253f2e9e 61 fields · synced May 17, 2026
- EUDAMED c66880eb-0323-4127-b6a1-72fa860d9693 61 fields · synced May 17, 2026
- EUDAMED a30cf5bc-1f5a-4d55-8764-1259436b3266 61 fields · synced May 19, 2026