← Back to catalogue
Sterilization Insert, for RemeOs™ Instruments
EUDAMEDFDA UDIClass I (EU MDR)
Ref B-IRC-9001
Identity
- Trade Name
- Sterilization Insert, for RemeOs™ Instruments EUDAMEDRemeOs Instrument FDA UDI
- Generic Name
- Surgical instrument/implant rack FDA UDI
- Device Name
- Sterilization Tray EUDAMEDSterilization Insert, for RemeOs™ Instruments FDA UDI
- Model / Reference
- B-IRC-9001 EUDAMEDFDA UDI
- Description
- Sterilization Insert, for RemeOs™ Instruments FDA UDI
Identifiers
- Catalog Number
- B-IRC-9001 FDA UDI
- Primary DI / UDI-DI
- 06438394015777 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438394INS015WR EUDAMED
- Direct Marketing DI
- 06438394015777 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Surgical instrument/implant rack FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Instrument tray, reusable
Sterilization Insert, for RemeOs™ Instruments by Bioretec Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Instrument tray, reusable.
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- Instrument Case — Katena Products, Inc. · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- SHEFFIELD RING FIXATOR — Orthofix, Inc. · Class II
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- ASELTECH — Asel Tibbi Aletler A.S. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6438394INS015WR | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (2)
- EUDAMED e8a6ed97-bba9-4abe-b0c7-a964e399836b 61 fields · synced Jul 13, 2026
- FDA UDI 4e48f5d6-c1ad-4b61-b099-5cc0fc00de8d 35 fields · synced May 22, 2026