TESSYS® Crown Reamer, violet, coarse
EUDAMEDFDA UDIClass IIa (EU MDR)
by Joimax GmbH
Identity
- Trade Name
- TESSYS® Crown Reamer, violet, coarse EUDAMEDTESSYS® FDA UDI
- Generic Name
- Bone-resection orthopaedic reamer, single-use FDA UDI
- Device Name
- TESSYS® Crown Reamer, violet, coarse EUDAMEDFDA UDICESSYS® Cervical Reamer EUDAMED
- Model / Reference
- CRC217585 EUDAMEDFDA UDI
- Description
- TESSYS® Crown Reamer, violet, coarse FDA UDI
Identifiers
- Catalog Number
- CRC217585 FDA UDI
- Primary DI / UDI-DI
- 04250337100256 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337100256 EUDAMED42503371REAMREAFD EUDAMED
- Direct Marketing DI
- 04250337100256 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® Crown Reamer, violet, coarse 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-04250337100256 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04250337100256 | 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 02d34ec5-34f0-43ee-8975-54bc34981ad7 61 fields · synced Jul 26, 2026
- FDA UDI 92d9d17c-f141-4787-893a-ccf06c2c453d 36 fields · synced May 30, 2026
- EUDAMED 8d0d0278-d4fb-4cf2-b3ba-3f4e17398278 61 fields · synced Jun 19, 2026