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GEMS Soft Harvest System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref DCALINJ1709-01Model DC1SLINJ1709-01
Identity
- Trade Name
- GEMS Soft Harvest System EUDAMEDTulip GEMS™ AlphaLuer Single-Use FDA UDI
- Generic Name
- Liposuction system cannula, single-use FDA UDI
- Device Name
- GEMS Tulip Injector (Single) EUDAMEDSingle-Use AlphaLuer Injector Cannula, 1.4mm x 9cm FDA UDI
- Model / Reference
- DC1SLINJ1709-01 EUDAMEDDCALINJ1709-01 EUDAMEDFDA UDI
- Description
- Single-Use AlphaLuer Injector Cannula, 1.4mm x 9cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00819127023188 EUDAMEDFDA UDI
- Basic UDI-DI
- 081912702DCINJ2L EUDAMED
- Direct Marketing DI
- 00819127023188 EUDAMED
- FDA Product Code
- QPB FDA UDI
- EMDN Code
- K01020110 MINIMALLY INVASIVE SURGERY CANNULAS, SINGLE-USE EUDAMED
- GMDN Term
- Liposuction system cannula, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.5040 FDA UDI
- Market of Registration
- Sweden 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
No
FDA UDI
GEMS Soft Harvest System by Tulip Medical Products, 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 | 081912702DCINJ2L | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Tulip Medical Products, Inc.
- EUDAMED SRN
- US-MF-000049097
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 9d5ee6b4-1e3f-49e6-8d5b-2283a4a8e839 61 fields · synced Jun 19, 2026
- FDA UDI 77b4b063-1148-4aaf-9817-74a3f5b94031 33 fields · synced May 30, 2026