TESSYS® Endoscopic Reamer
EUDAMEDFDA UDIClass IIa (EU MDR)
by Joimax GmbH
Identity
- Trade Name
- TESSYS® Endoscopic Reamer EUDAMEDTESSYS® FDA UDI
- Generic Name
- Bone-resection orthopaedic reamer, single-use FDA UDI
- Device Name
- TESSYS® Endoscopic Reamer EUDAMEDFDA UDICESSYS® Cervical Reamer EUDAMED
- Model / Reference
- TER352835 EUDAMEDFDA UDI
- Description
- TESSYS® Endoscopic Reamer FDA UDI
Identifiers
- Catalog Number
- TER352835 FDA UDI
- Primary DI / UDI-DI
- 04250337101215 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337101215 EUDAMED42503371REAMREAFD EUDAMED
- Direct Marketing DI
- 04250337101215 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: General internal orthopaedic fixation system implantation kit
TESSYS® Endoscopic Reamer by Joimax GmbH — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04250337101215 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04250337101215 | 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 dd9fb4d1-2359-4e65-9c9d-09074351712e 61 fields · synced Jul 20, 2026
- FDA UDI a2a9093e-8512-46cb-9881-78e7f8441cc2 36 fields · synced May 30, 2026
- EUDAMED 2e820927-4698-4d87-92f9-0ef3cd526df8 61 fields · synced Jul 9, 2026