Identity
- Trade Name
- LevaLap EUDAMEDLevaLap 1.0 FDA UDI
- Generic Name
- Laparoscopic access suction dome FDA UDI
- Device Name
- LevaLap Laparoscopic Access Device EUDAMEDLaparasopic access device FDA UDI
- Model / Reference
- DMT-001 EUDAMEDFDA UDI
- Description
- Laparasopic access device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860006094201 EUDAMEDFDA UDI
- Basic UDI-DI
- 8600060942LLD4 EUDAMED
- 510(k) Number
- K212786 FDA UDI
- FDA Product Code
- HIF FDA UDI
- EMDN Code
- V9012 NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
- GMDN Term
- Laparoscopic access suction dome FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1730 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Surgical retractor/retraction system blade, single-use
LevaLap by Core Access Surgical Technologies, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical retractor/retraction system blade, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8600060942LLD4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Core Access Surgical Technologies, Inc.
- EUDAMED SRN
- US-MF-000033149
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 3624c217-c569-4918-aed9-8eb917ff5111 61 fields · synced Jun 9, 2026
- FDA UDI 3f35f5aa-2c72-456e-963a-d3a9b300e9bf 35 fields · synced May 30, 2026