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Mios
EUDAMEDFDA UDIClass I (EU MDR)
Ref FK217RRef FK235RRef FK212RRef FK247RRef FK234R
by Aesculap AG
Identity
- Trade Name
- MIOS EUDAMEDFDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- MIOS retractor EUDAMEDMIOS Hip Retractor, 90 °, 9 1/2" (240 mm), standard, sharp, width: 28 mm FDA UDI
- Model / Reference
- FK217R EUDAMEDFK235R EUDAMEDFK212R EUDAMEDFDA UDIFK247R EUDAMEDFK234R EUDAMED
- Description
- MIOS Hip Retractor, 90 °, 9 1/2" (240 mm), standard, sharp, width: 28 mm FDA UDI
Identifiers
- Catalog Number
- FK212R FDA UDI
- Primary DI / UDI-DI
- 04046955282524 EUDAMED04046955297276 EUDAMED04038653456147 EUDAMEDFDA UDI04046955282548 EUDAMED04046955282555 EUDAMED
- Basic UDI-DI
- 403923900000038026 EUDAMED
- Direct Marketing DI
- 04046955282524 EUDAMED04046955297276 EUDAMED04038653456147 EUDAMED04046955282548 EUDAMED04046955282555 EUDAMED
- FDA Product Code
- GAD FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Mios by Aesculap AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 403923900000038026 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (6)
- EUDAMED 400b2871-97aa-483e-b53e-394c58e1bdba 61 fields · synced Sep 30, 2026
- EUDAMED 87c580c3-f686-4eeb-a6c0-43b263d10e69 61 fields · synced May 17, 2026
- EUDAMED e1f1a52c-b0cd-40db-9938-23b52f54d7d5 61 fields · synced May 18, 2026
- EUDAMED 9e980429-1ca2-4782-bc46-d73714619661 61 fields · synced May 18, 2026
- EUDAMED 4a01ae6d-f543-4934-8ff1-513094b739bb 61 fields · synced May 19, 2026
- FDA UDI c80904b2-6608-458f-8803-1f3138997b67 35 fields · synced May 30, 2026