Identity
- Trade Name
- EXEL SCALPELS ,S-S, SIZE:22 EUDAMEDEXEL Disposable Scalpel, Stainless Steel Size 22 EUDAMEDEXEL Disposable Scalpel Size 22 SS FDA UDI
- Generic Name
- Scalpel, single-use FDA UDI
- Device Name
- EXEL SCALPEL EUDAMEDEXEL Disposable Scalpel EUDAMED
- Model / Reference
- 29559 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 29559 FDA UDI
- Primary DI / UDI-DI
- 00020221295597 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00020221295597 EUDAMED20221SCPL2953Z EUDAMED
- FDA Product Code
- GES FDA UDI
- EMDN Code
- V010102 SCALPELS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
- GMDN Term
- Scalpel, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Netherlands EUDAMEDAustria 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Scalpel, single-use
Exel Scalpels , S-S, Size:22 by Exelint International, Co. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Scalpel, single-use.
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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-00020221295597 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00020221295597 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Exelint International, Co.
- EUDAMED SRN
- US-MF-000037396
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 8e2e4066-e473-430b-8093-e51c76eebbdd 61 fields · synced Jul 16, 2026
- FDA UDI bb5765d7-935f-4e8d-9dc3-8ff50777896c 34 fields · synced May 30, 2026
- EUDAMED 12486c48-7455-47e1-a81c-115dfd75c489 61 fields · synced Jul 16, 2026