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Reveel
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref RV093001Model Laparoscopic Retractor- Percutaneous
Identity
- Trade Name
- REVEEL EUDAMEDREVEEL - Endoscopic Retractor - Percutaneous FDA UDI
- Generic Name
- Hand-held endoscopic retractor, single-use FDA UDI
- Device Name
- REVEEL Laparoscopic Retractor EUDAMED
- Model / Reference
- Laparoscopic Retractor- Percutaneous EUDAMEDRV093001 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811099014386 EUDAMEDFDA UDI
- Basic UDI-DI
- 081109901DOC013SC EUDAMED
- Unit of Use DI
- 00811099014379 EUDAMED
- 510(k) Number
- K133345 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- K01020106 MINIMALLY INVASIVE SURGERY SPREADERS AND RETRACTORS, SINGLE-USE EUDAMED
- GMDN Term
- Hand-held endoscopic retractor, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Reveel by Microline Surgical, Inc. — Class IIa — 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 | 081109901DOC013SC | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Microline Surgical, Inc.
- EUDAMED SRN
- US-MF-000009811
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 0a5e8499-18fd-4c55-93a5-30e2986bcacb 61 fields · synced Jul 25, 2026
- FDA UDI cdc64292-7dca-4cfe-9313-9778be161d45 33 fields · synced May 30, 2026