Identity
- Trade Name
- Rigicon EUDAMEDRigicon HL Dilator 11 – 12 mm FDA UDI
- Generic Name
- Penile prosthesis implantation instrument FDA UDI
- Device Name
- Rigicon HL Dilator (Sterile) EUDAMEDRigicon HL Dilator 11 – 12 mm Disposable FDA UDI
- Model / Reference
- RSUD-1112 EUDAMEDFDA UDI
- Description
- Rigicon HL Dilator 11 – 12 mm Disposable FDA UDI
Identifiers
- Catalog Number
- RSUD-1112 FDA UDI
- Primary DI / UDI-DI
- 00850015358418 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850015358418S9 EUDAMED
- Direct Marketing DI
- 00850015358418 EUDAMED
- FDA Product Code
- KOA FDA UDI
- EMDN Code
- K01020117 MINIMALLY INVASIVE SURGERY DILATORS, SINGLE-USE EUDAMED
- GMDN Term
- Penile prosthesis implantation instrument FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.4730 FDA UDI
- Market of Registration
- Türkiye 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Rigicon by Rigicon, Inc. — 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 | 0850015358418S9 | 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
- Rigicon, Inc.
- EUDAMED SRN
- US-MF-000027758
- Authorised Representative
- Rigicon B.V. NL-AR-000013173
Sources (2)
- EUDAMED beb32bc4-a436-44b1-9a01-5d28897d1e4e 61 fields · synced Jul 23, 2026
- FDA UDI e78ffae5-a0e9-486e-8ac9-bcaecede48ec 34 fields · synced May 30, 2026