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Disposable Gold Kit
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref DPK-GOLD-05Model DPK-GOLD-01
Identity
- Trade Name
- DISPOSABLE GOLD KIT EUDAMEDTulip GEMS™ Single-Use FDA UDI
- Generic Name
- Autologous adipose tissue reinjection set FDA UDI
- Device Name
- Disposable Gold Kit EUDAMEDDisposable Gold Kit 5 Pack FDA UDI
- Model / Reference
- DPK-GOLD-01 EUDAMEDDPK-GOLD-05 EUDAMEDFDA UDI
- Description
- Disposable Gold Kit 5 Pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00819127024130 EUDAMEDFDA UDI
- Basic UDI-DI
- 081912702DPK-GOLDEN EUDAMED
- Direct Marketing DI
- 00819127024130 EUDAMED
- EMDN Code
- K01020110 MINIMALLY INVASIVE SURGERY CANNULAS, SINGLE-USE EUDAMED
- GMDN Term
- Autologous adipose tissue reinjection set FDA UDI
Classification
- Device Class
- Class IIa EUDAMED
- 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
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Disposable Gold 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-GOLDEN | 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 0eefd7c7-fc0b-4b65-8041-aa61932cc902 61 fields · synced Jul 9, 2026
- FDA UDI 0302d520-b198-4b8f-9105-7e39aaf5fd4c 33 fields · synced May 30, 2026