REMA Shaver Blades
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- REMA Shaver Blades FDA UDI
- Generic Name
- Arthroscopic shaver system blade, reusable FDA UDI
- Device Name
- ShaverBlades EUDAMEDFULL-RADIUS-RESECTOR 3,4 Ø MM, FDA UDI
- Model / Reference
- 15-61210 EUDAMED15-60441 EUDAMED15-60330 FDA UDI
- Description
- FULL-RADIUS-RESECTOR 3,4 Ø MM, FDA UDI
Identifiers
- Catalog Number
- 15-60330 FDA UDI
- Primary DI / UDI-DI
- 04035282353311 EUDAMED04035282353212 EUDAMED04059223157806 FDA UDI
- Basic UDI-DI
- 4035282REMAShaverBlades3W EUDAMED
- Direct Marketing DI
- 04035282353311 EUDAMED04035282353212 EUDAMED
- FDA Product Code
- HRX FDA UDI
- EMDN Code
- L1999 ARTHROSCOPIC SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Arthroscopic shaver system blade, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.1100 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Arthroscopic shaver system blade, reusable
REMA Shaver Blades by DEWIMED Medizintechnik GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Arthroscopic shaver system blade, reusable.
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- EBERLE — Eberle GmbH & Co. KG · Class II
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- Eberle Shaver Blades — Eberle GmbH & Co. KG · Class II
- EBERLE — Eberle GmbH & Co. KG · Class II
- EBERLE — Eberle GmbH & Co. KG · Class II
- EBERLE — Eberle GmbH & Co. KG · Class II
- EBERLE — Eberle GmbH & Co. KG · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- DEWIMED Medizintechnik GmbH
Sources (3)
- FDA UDI 9ba0f4f4-796c-4be4-99d6-f867d0337708 34 fields · synced Jul 27, 2026
- EUDAMED 7b056bca-ebdc-42fb-922b-417cf7810933 61 fields · synced Jul 14, 2026
- EUDAMED f68b9092-4bc7-4fb1-9f59-1558cd5bff7a 61 fields · synced Jul 27, 2026