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Rigicon
EUDAMEDFDA UDIClass I (EU MDR)
Ref RSRK-1000Model RSRK-1000 Rigicon Surgical Retractor Kit
Identity
- Trade Name
- Rigicon EUDAMEDRIGICON SURGICAL RETRACTOR FDA UDI
- Generic Name
- Surgical retraction system, single-use FDA UDI
- Device Name
- Rigicon Surgical Retractor Kit EUDAMEDRigicon® Surgical Retractor FDA UDI
- Model / Reference
- RSRK-1000 Rigicon Surgical Retractor Kit EUDAMEDRSRK-1000 EUDAMEDFDA UDI
- Description
- Rigicon® Surgical Retractor FDA UDI
Identifiers
- Catalog Number
- RSRK-1000 FDA UDI
- Primary DI / UDI-DI
- 00850015358746 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00850015358746 EUDAMED
- FDA Product Code
- GAD FDA UDI
- EMDN Code
- L06050299 NON-ENDOSCOPIC UROLOGY RETRACTORS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical retraction system, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00850015358746 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Rigicon, Inc.
- EUDAMED SRN
- US-MF-000027758
- Authorised Representative
- Rigicon B.V. NL-AR-000013173
Sources (2)
- EUDAMED 558cf95c-1d2d-4997-9ddb-edfd2c0f8d2f 61 fields · synced Jul 12, 2026
- FDA UDI 72b69241-ef85-44cd-be7e-3550491a6d1f 34 fields · synced May 30, 2026