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GEMS Soft Harvest System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref DCALINF1415-10Model DC1SLINF1412-01
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 Tumescent Infiltrator EUDAMEDSingle-Use AlphaLuer Infiltrator Cannula, 2.1mm x 15cm, Set of 10 FDA UDI
- Model / Reference
- DC1SLINF1412-01 EUDAMEDDCALINF1415-10 EUDAMEDFDA UDI
- Description
- Single-Use AlphaLuer Infiltrator Cannula, 2.1mm x 15cm, Set of 10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00819127023317 EUDAMEDFDA UDI
- Basic UDI-DI
- 081912702DCINF2C EUDAMED
- Direct Marketing DI
- 00819127023317 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 | 081912702DCINF2C | 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 9bea21b3-fe48-4e78-9d08-6b29c3c959da 61 fields · synced Jun 19, 2026
- FDA UDI a7d39f62-c525-4828-8acf-e5fe7b538cbb 33 fields · synced May 30, 2026