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Soft Breast Microfat + True Nanofat Kit
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref DPK-SFB-TNF-01
Identity
- Trade Name
- SOFT BREAST MICROFAT + TRUE NANOFAT KIT EUDAMEDTulip GEMS™ Single-Use FDA UDI
- Generic Name
- Autologous adipose tissue reinjection set FDA UDI
- Device Name
- SOFT BREAST MICROFAT + TRUE NANOFAT KIT EUDAMEDSingle-Use SoftBreast MicroFat + True NanoFat Kit FDA UDI
- Model / Reference
- DPK-SFB-TNF-01 EUDAMEDFDA UDI
- Description
- Single-Use SoftBreast MicroFat + True NanoFat Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00819127022808 EUDAMEDFDA UDI
- Basic UDI-DI
- 081912702DPK-SFB-TNF34 EUDAMED
- Direct Marketing DI
- 00819127022808 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Soft Breast Microfat + True Nanofat Kit 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 | 081912702DPK-SFB-TNF34 | 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 1d61dc39-674b-4973-9b4c-12147c90d105 61 fields · synced Jun 19, 2026
- FDA UDI 78986f98-b27f-4c40-a7e6-8d66e437cce7 33 fields · synced May 30, 2026