Identity
- Trade Name
- TESSYS® Crown Reamer, green, coarse EUDAMEDTESSYS® FDA UDI
- Generic Name
- Bone-resection orthopaedic reamer, single-use FDA UDI
- Device Name
- CESSYS® Cervical Reamer EUDAMEDTESSYS® Crown Reamer, green, coarse FDA UDI
- Model / Reference
- CRC214250 EUDAMEDFDA UDI
- Description
- TESSYS® Crown Reamer, green, coarse FDA UDI
Identifiers
- Catalog Number
- CRC214250 FDA UDI
- Primary DI / UDI-DI
- 04250337100225 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371REAMREAFD EUDAMED
- Direct Marketing DI
- 04250337100225 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
Category: Bone-resection orthopaedic reamer, single-use
Tessys® by Joimax, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Joimax, Inc.
Sources (2)
- FDA UDI 2cf6d52f-a607-4980-836f-cefd490ff59c 36 fields · synced Jul 21, 2026
- EUDAMED 182cea8d-0ec7-43c9-8800-d7b8f4f69f10 61 fields · synced Jul 21, 2026