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GEMS Single-use Anaerobic Sizing Transfers
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref MICROFAT FOR ONE PATIENT KIT (Single)Model DMICRO-01
Identity
- Trade Name
- GEMS Single-use Anaerobic Sizing Transfers EUDAMEDTulip GEMS™ Single-Use FDA UDI
- Generic Name
- Autologous adipose tissue reinjection set FDA UDI
- Device Name
- MICROFAT FOR ONE PATIENT KIT (Single) EUDAMEDSingle-Use MicroFat Set for 1 Patients FDA UDI
- Model / Reference
- DMICRO-01 EUDAMEDFDA UDIMICROFAT FOR ONE PATIENT KIT (Single) EUDAMED
- Description
- Single-Use MicroFat Set for 1 Patients FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00819127023928 EUDAMEDFDA UDI
- Basic UDI-DI
- 081912702DMICRO5J EUDAMED
- Direct Marketing DI
- 00819127023928 EUDAMED
- FDA Product Code
- QPB FDA UDI
- EMDN Code
- K01020110 MINIMALLY INVASIVE SURGERY CANNULAS, SINGLE-USE EUDAMED
- GMDN Term
- Autologous adipose tissue reinjection set 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
Yes
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 Single-use Anaerobic Sizing Transfers by Tulip Medical Products, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 081912702DMICRO5J | 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 7b5f29e7-f68f-4f30-b9c0-7bd87f926940 61 fields · synced Jul 22, 2026
- FDA UDI 5c08c3f8-c5de-447f-af8a-e5187a6da92b 33 fields · synced May 30, 2026