Identity
- Trade Name
- Novatome EUDAMEDFDA UDI
- Generic Name
- Endomyocardial biopsy forceps, single-use FDA UDI
- Device Name
- Novatome Endomyocardial Biopsy Forceps EUDAMED
- Model / Reference
- SU103-100PC EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00866215000064 EUDAMEDFDA UDI
- Basic UDI-DI
- 08662150000NOVATOMEWK EUDAMED
- 510(k) Number
- K072051 FDA UDI
- FDA Product Code
- DWZ FDA UDI
- EMDN Code
- C01901102 MYOCARDIAL BIOPSY KITS EUDAMED
- GMDN Term
- Endomyocardial biopsy forceps, single-use FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.4075 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Novatome by Scholten Surgical Instruments, Inc. — Class III — 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 | 08662150000NOVATOMEWK | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Scholten Surgical Instruments, Inc.
- EUDAMED SRN
- US-MF-000034588
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 0b79b0a5-9952-4ce1-aa64-b22270c55773 61 fields · synced May 29, 2026
- FDA UDI 155709fa-3794-4c80-8953-ec5fc76e442f 34 fields · synced May 29, 2026