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Custom 32cm/13in-40cm/16in Proximal Circumference
EUDAMEDFDA UDIClass I (EU MDR)
Ref SLR32-40 CUSTOM
Identity
- Trade Name
- Custom 32cm/13in-40cm/16in Proximal Circumference EUDAMEDSILICONE SLEEVE FDA UDI
- Generic Name
- External lower-limb prosthesis suspensory component, non-powered FDA UDI
- Device Name
- SILICONE SLEEVE EUDAMEDCustom 32cm/13in-40cm/16in Proximal Circumference FDA UDI
- Model / Reference
- SLR32-40 CUSTOM EUDAMEDFDA UDI
- Description
- Custom 32cm/13in-40cm/16in Proximal Circumference FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00713980001973 EUDAMEDFDA UDI
- Basic UDI-DI
- 0713980100020087E EUDAMED
- FDA Product Code
- ISS FDA UDI
- EMDN Code
- Y062409 TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE) EUDAMED
- GMDN Term
- External lower-limb prosthesis suspensory component, non-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3420 FDA UDI
- Market of Registration
- Italy 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Custom 32cm/13in-40cm/16in Proximal Circumference by Alps South, LLC — 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 | 0713980100020087E | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Alps South, LLC
- EUDAMED SRN
- US-MF-000001260
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 452309ae-15e7-4e4c-9e47-7529a90f575e 61 fields · synced Sep 30, 2026
- FDA UDI d86123ca-fd65-48c0-ae7a-ddc632a9ef89 33 fields · synced May 30, 2026