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Attune
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2544-00-111Model Attune Fixation pins instrument
Identity
- Trade Name
- ATTUNE EUDAMEDFDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
- Device Name
- Fixation pins instrument EUDAMEDATTUNE PINNING SYSTEM FDA UDI
- Model / Reference
- Attune Fixation pins instrument EUDAMED2544-00-111 EUDAMEDFDA UDI
- Description
- ATTUNE PINNING SYSTEM FDA UDI
Identifiers
- Catalog Number
- 254400111 FDA UDI
- Primary DI / UDI-DI
- 10603295129943 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a0001889 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- 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
CMR Substance
Yes
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
Prescription Use
No
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
Attune by DePuy Ireland UC — Class IIa — MDR, 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/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0603295a0001889 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED 0fbd0131-cedf-40d2-a851-cc0404823b85 61 fields · synced Jul 9, 2026
- FDA UDI f74ce5f1-7514-4d6a-9abb-b6934cefd846 35 fields · synced May 29, 2026