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TESSYS® Crown Reamer, red, fine
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref CRF216575
by Joimax GmbH
Identity
- Trade Name
- TESSYS® Crown Reamer, red, fine EUDAMEDTESSYS® FDA UDI
- Generic Name
- Bone-resection orthopaedic reamer, single-use FDA UDI
- Device Name
- TESSYS® Crown Reamer, red, fine EUDAMEDFDA UDICESSYS® Cervical Reamer EUDAMED
- Model / Reference
- CRF216575 EUDAMEDFDA UDI
- Description
- TESSYS® Crown Reamer, red, fine FDA UDI
Identifiers
- Catalog Number
- CRF216575 FDA UDI
- Primary DI / UDI-DI
- 04250337100294 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337100294 EUDAMED42503371REAMREAFD EUDAMED
- Direct Marketing DI
- 04250337100294 EUDAMED
- FDA Product Code
- HTO FDA UDI
- EMDN Code
- V901699 SPECIALIST SURGICAL INSTRUMENTS AND KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Bone-resection orthopaedic reamer, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
TESSYS® Crown Reamer, red, fine by Joimax GmbH — Class IIa — 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-04250337100294 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04250337100294 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Joimax GmbH
- EUDAMED SRN
- DE-MF-000009201
Sources (3)
- EUDAMED aac5026f-9b51-44bd-a0dc-1575b52008d7 61 fields · synced Jul 22, 2026
- FDA UDI b800f279-8ab9-486d-a64e-e76eb265db39 36 fields · synced May 30, 2026
- EUDAMED 8a9cb16a-4acd-49e2-b1e0-145112cd85e6 61 fields · synced Jul 22, 2026