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GEMS Soft Harvest System
EUDAMEDClass IIa (EU MDR)
Ref DCALINJ1807-10Model DC1SLINJ1709-01
Identity
- Trade Name
- GEMS Soft Harvest System EUDAMED
- Device Name
- GEMS Tulip Injector (Single) EUDAMED
- Model / Reference
- DC1SLINJ1709-01 EUDAMEDDCALINJ1807-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00819127023195 EUDAMED
- Basic UDI-DI
- 081912702DCINJ2L EUDAMED
- Direct Marketing DI
- 00819127023195 EUDAMED
- EMDN Code
- K01020110 MINIMALLY INVASIVE SURGERY CANNULAS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
GEMS Soft Harvest System by Tulip Medical Products, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081912702DCINJ2L | Class IIa | Active |
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Manufacturer
- Manufacturer
- Tulip Medical Products, Inc.
- EUDAMED SRN
- US-MF-000049097
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED 762b596a-0053-493d-a72c-f4604e04c33a 61 fields · synced Oct 6, 2026