Identity
- Trade Name
- Tulip Adapter EUDAMEDFDA UDITulipadapter EUDAMED
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Tulip Adapter EUDAMEDFDA UDITulipadapter EUDAMED
- Model / Reference
- JMPS1051R EUDAMEDFDA UDI
- Description
- Tulip Adapter FDA UDI
Identifiers
- Catalog Number
- JMPS1051R FDA UDI
- Primary DI / UDI-DI
- 04250337110538 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337110538 EUDAMED42503371INSRTULQ2 EUDAMED
- Direct Marketing DI
- 04250337110538 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L1199 NEUROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass IIa EUDAMED
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Austria EUDAMEDGermany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMEDEUDAMED
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Tulip Adapter by Joimax GmbH — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04250337110538 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04250337110538 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Joimax GmbH
- EUDAMED SRN
- DE-MF-000009201
Sources (3)
- EUDAMED 1eaaba21-ce82-4676-9a74-33020e62258e 61 fields · synced Jul 11, 2026
- FDA UDI 92de5c9f-b3b8-4950-a4c5-d440bd7cc93a 35 fields · synced May 30, 2026
- EUDAMED 9c419c41-d979-41b2-974f-4ba1a28385c9 61 fields · synced Jul 11, 2026