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Scaler 204sd (3/8) Yellow - Swede Dent
EUDAMEDFDA UDIClass I (EU MDR)
Ref SIS204SDXC
Identity
- Trade Name
- SCALER 204SD (3/8) YELLOW - SWEDE DENT EUDAMEDSwede Dental FDA UDI
- Generic Name
- Manual dental scaler, reusable FDA UDI
- Device Name
- Periodontal Curette EUDAMEDSCALER 204SD (3/8) YELLOW FDA UDI
- Model / Reference
- SIS204SDXC EUDAMEDFDA UDI
- Description
- SCALER 204SD (3/8) YELLOW FDA UDI
Identifiers
- Catalog Number
- SIS204SDXC FDA UDI
- Primary DI / UDI-DI
- 00841013117909 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841013141660EMSA737883F3 EUDAMED
- FDA Product Code
- EMN FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Manual dental scaler, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not 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
No
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
Scaler 204sd (3/8) Yellow - Swede Dent by American Eagle Instruments — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 0841013141660EMSA737883F3 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- American Eagle Instruments
- EUDAMED SRN
- US-MF-000018222
- Authorised Representative
- Young Microbrush Ireland Ltd IE-AR-000011249
Sources (2)
- EUDAMED bddbf760-bb00-4186-abc0-5e972d88c4a2 61 fields · synced Jul 9, 2026
- FDA UDI e1cfe7e7-e221-4f00-a131-ba6d16ac2ece 36 fields · synced May 30, 2026