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CESSYS® Crown Dilator, red
EUDAMEDFDA UDIClass I (EU MDR)
Ref CCR152039
by Joimax GmbH
Identity
- Trade Name
- CESSYS® Crown Dilator, red EUDAMEDCESSYS® FDA UDI
- Generic Name
- Endoscopic-access dilator, reusable FDA UDI
- Device Name
- Crown Dilator EUDAMEDCESSYS® Crown Dilator, red EUDAMEDFDA UDI
- Model / Reference
- CCR152039 EUDAMEDFDA UDI
- Description
- CESSYS® Crown Dilator, red FDA UDI
Identifiers
- Catalog Number
- CCR152039 FDA UDI
- Primary DI / UDI-DI
- 04250337108320 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371REAMDILE9 EUDAMEDB-04250337108320 EUDAMED
- FDA Product Code
- NBH FDA UDI
- EMDN Code
- L1113 NEUROSURGERY BURS AND TIPS, REUSABLE EUDAMED
- GMDN Term
- Endoscopic-access dilator, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.1100 FDA UDI
- Market of Registration
- Germany 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
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
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
CESSYS® Crown Dilator, red by Joimax GmbH — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 42503371REAMDILE9 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 42503371REAMDILE9 | 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 3377dfc6-85b4-4f3a-b784-52a05edd71d3 61 fields · synced Jul 10, 2026
- EUDAMED 8d4a08d7-4d46-4be8-96b8-273335604e41 61 fields · synced May 19, 2026
- FDA UDI ba6d4ab9-bd25-46d1-9591-ee6c467f868e 36 fields · synced May 30, 2026