Identity
- Trade Name
- 2.0-3.5 Plate Holding Forceps EUDAMEDAPTUS FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Plate holding & positioning Instruments EUDAMED2.0-3.5 Plate Holding Forceps FDA UDI
- Model / Reference
- A-2050 EUDAMEDFDA UDI
- Description
- 2.0-3.5 Plate Holding Forceps FDA UDI
Identifiers
- Catalog Number
- A-2050 FDA UDI
- Primary DI / UDI-DI
- 07630037873013 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300378010P3 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: General internal orthopaedic fixation system implantation kit
Aptus by Medartis Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medartis Inc.
Sources (2)
- FDA UDI 711e3518-e00e-4fc9-b6c7-2e385e79d53e 34 fields · synced Jul 21, 2026
- EUDAMED 6f37dac9-5e23-4b65-a0ce-095f97cc21dd 61 fields · synced Jul 21, 2026