Identity
- Trade Name
- Dental Instrument EUDAMEDMulti Pick-up Impression Coping EUDAMEDDental Implants Accesseories-Single Use FDA UDI
- Generic Name
- Dental impression tray, single-use FDA UDI
- Device Name
- Multi Pick-up Impression Coping EUDAMEDCOWELL® Reusable Surgical Instrument EUDAMED
- Model / Reference
- 2SMIH45 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800016100587 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800016100587 EUDAMED880947172M01D04U08M4 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental impression tray, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dental Instrument by Cowellmedi Co., Ltd — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08800016100587 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-08800016100587 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cowellmedi Co., Ltd.
- EUDAMED SRN
- KR-MF-000009689
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (3)
- EUDAMED bd40e857-b303-42cd-ba25-dd4a95970098 61 fields · synced Jul 10, 2026
- FDA UDI 454d1070-40f8-42af-8f78-06aeb66b0cf3 32 fields · synced May 30, 2026
- EUDAMED 7fe86e52-7014-4abe-9347-b1d30d8ebc74 61 fields · synced Jun 14, 2026