← Back to catalogue
Implant Case APTUS Foot Plates 2.8/3.5
EUDAMEDFDA UDIClass I (EU MDR)
Ref A-6601.030Ref A-6601.068Ref A-6601.091Ref A-6601.090Ref A-6601.067
by Medartis AG
Identity
- Trade Name
- Implant Case APTUS Foot Plates 2.8/3.5 EUDAMEDImplant Case APTUS Foot Plates 2.8 EUDAMEDAPTUS FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- Container EUDAMEDImplant Case APTUS Foot Plates 2.8 FDA UDIImplant Case APTUS Foot Plates 2.8/3.5 FDA UDI
- Model / Reference
- A-6601.030 EUDAMEDFDA UDIA-6601.067 EUDAMEDFDA UDIA-6601.068 EUDAMEDFDA UDIA-6601.091 EUDAMEDA-6601.090 EUDAMED
- Description
- Implant Case APTUS Foot Plates 2.8 FDA UDIImplant Case APTUS Foot Plates 2.8/3.5 FDA UDI
Identifiers
- Catalog Number
- A-6601.067 FDA UDIA-6601.068 FDA UDIA-6601.030 FDA UDI
- Primary DI / UDI-DI
- 07630894803062 EUDAMEDFDA UDI07630037853336 EUDAMEDFDA UDI07630894803154 EUDAMEDFDA UDI07630037853343 EUDAMEDFDA UDI07630894807725 EUDAMED07630894807763 EUDAMED
- Basic UDI-DI
- 76300378000NY EUDAMED
- 510(k) Number
- K193639 FDA UDI
- FDA Product Code
- HRS FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDIFDA UDI
Serial Number
No
FDA UDIFDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Device sterilization/disinfection container, reusable
Implant Case APTUS Foot Plates 2.8/3.5 by Medartis AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Device sterilization/disinfection container, reusable.
- SM - LIPO PANTY CHEVILLES COUPE TAILLE NOIR AVEC TROUS RECOUVERTS SUR MESURE — MEDICAL Z · Class I
- APTUS — Medartis Inc. · Class I
- APTUS — Medartis Inc. · Class II
- INSTRUMENTS TRAYS WITHOUT LID, 200x100x25MM — DAUD JEE MFG. CO · Class I
- Breastform Cover Right Size 03 (478/ 482) — Trulife · Class I
- NCB® Periprosthetic Plate System — Zimmer, Inc. · Class I
- NTOC cassette — NTOC medische techniek B.V · Class I
- MIRABOR-CA (12 BURS)- — Hager Worldwide, Inc. · Class I
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 | 76300378000NY | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medartis AG
- EUDAMED SRN
- CH-MF-000022291
- Authorised Representative
- Medartis GmbH DE-AR-000005810
Sources (10)
- EUDAMED ad1b8442-4f8e-43fa-8c41-a09c870a3daf 61 fields · synced Oct 6, 2026
- FDA UDI 2b50a625-7fc9-4811-a388-872acf8e4a2e 35 fields · synced May 29, 2026
- FDA UDI 089bf03b-09bd-4398-a9b8-e04a08fb9ed4 35 fields · synced May 30, 2026
- FDA UDI 072b8b2c-640d-46bf-ac7c-be7eec43ff82 35 fields · synced May 30, 2026
- FDA UDI b422d12f-f728-414e-b13e-1ac0f032225d 35 fields · synced May 30, 2026
- EUDAMED a1a45a58-e6e9-4861-9c64-9549844ac773 61 fields · synced Jul 10, 2026
- EUDAMED f69cf876-5888-4693-8bde-2b119db60a7f 61 fields · synced Jul 12, 2026
- EUDAMED 10cd7392-1ff3-436a-91e7-e81c7a328957 61 fields · synced Jul 22, 2026
- EUDAMED d92bdb86-571a-4772-b707-faae5fb7126e 61 fields · synced Jul 22, 2026
- EUDAMED 80232393-03e9-4efd-bdef-56aa22015a26 61 fields · synced Jul 23, 2026