Identity
- Trade Name
- Rigid Probe EUDAMEDFDA UDI
- Generic Name
- Exploratory blunt needle, single-use FDA UDI
- Device Name
- Rigid Probe EUDAMED
- Model / Reference
- 202-3023 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- n/a FDA UDI
- Primary DI / UDI-DI
- 05060267130150 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060267130150 EUDAMED
- FDA Product Code
- GAB FDA UDI
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Exploratory blunt needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Slovenia EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Joint prosthesis implantation kit, single-use
Rigid Probe by Xiros Limited — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060267130150 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Xiros Limited
- EUDAMED SRN
- GB-MF-000004396
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED e0fb067a-5403-4d16-adb1-1ef22670bb1d 61 fields · synced Jun 1, 2026
- FDA UDI 0523df27-11df-4fca-9ba6-d4e0c0d68f6b 35 fields · synced May 30, 2026