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Beekley Corporation

United States·US-MF-000007055

Last updated September 17, 2026

Information

Country: United States
Address: 1 Prestige Lane, Bristol, United States
Website: beekley.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: —
EUDAMED SRN: US-MF-000007055
FDA FEI Number: 3000204334
DUNS Number: —

Catalogue (161)

Page 2 of 4

Device	Model / Reference	Registries	Class	Status
O-Spot	791	EUDAMEDFDA UDI	Class I	Active
TomoSPOT	784S	EUDAMEDFDA UDI	Class I	Active
TomoSPOT	781	EUDAMEDFDA UDI	Class I	Active
O-Spot	691	EUDAMEDFDA UDI	Class I	Active
Rt-Spot	130S	EUDAMEDFDA UDI	Class I	Active
Ct-Spot	119	EUDAMEDFDA UDI	Class I	Active
Bella Blankets	310	EUDAMEDFDA UDI	Class I	Active
Y-Spot	602	EUDAMEDFDA UDI	Class I	Active
O-Spot	791S	EUDAMEDFDA UDI	Class I	Active
Cradles	309	EUDAMEDFDA UDI	Class I	Active
PointGuards	115S	EUDAMEDFDA UDI	Class I	Active
Ct-Spot	118S	EUDAMEDFDA UDI	Class I	Active
Rt-Spot	127	EUDAMEDFDA UDI	Class I	Active
Altus	654	EUDAMEDFDA UDI	Class I	Active
S-Spot	607S	EUDAMEDFDA UDI	Class I	Active
O-Spot	652	EUDAMEDFDA UDI	Class I	Active
Z-Spot	114	EUDAMEDFDA UDI	Class I	Active
AccuGrid	300S	EUDAMEDFDA UDI	Class A	Active
InkRight	510	EUDAMEDFDA UDI	Class I	Active
N-Spot	653S	EUDAMEDFDA UDI	Class I	Active
D-Spot	104S	EUDAMEDFDA UDI	Class I	Active
A-Spot	651	EUDAMEDFDA UDI	Class I	Active
N-Spot	608	EUDAMEDFDA UDI	Class I	Active
A-Spot	651S	EUDAMEDFDA UDI	Class I	Active
S-Spot	650	EUDAMEDFDA UDI	Class I	Active
Altus	654S	EUDAMEDFDA UDI	Class I	Active
N-Spot	690S	EUDAMEDFDA UDI	Class I	Active
N-Spot	608S	EUDAMEDFDA UDI	Class I	Active
S-Spot	607	EUDAMEDFDA UDI	Class I	Active
PointGuards	215	EUDAMEDFDA UDI	Class I	Active
Mr-Spot	121	EUDAMEDFDA UDI	Class I	Active
CoreTainer	303S	EUDAMEDFDA UDI	Class A	Active
TomoSPOT	782	EUDAMEDFDA UDI	Class I	Active
O-Spot	609S	EUDAMEDFDA UDI	Class I	Active
N-Spot	790P	EUDAMEDFDA UDI	Class I	Active
TenderTouch	418	EUDAMEDFDA UDI	Class I	Active
V-Spot	703	EUDAMEDFDA UDI	Class I	Active
N-Spot	610	EUDAMEDFDA UDI	Class I	Active
Pinnacle	330S	EUDAMEDFDA UDI	Class I	Active
InkRight	510S	EUDAMEDFDA UDI	Class I	Active
O-Spot	609	EUDAMEDFDA UDI	Class I	Active
V-Spot	703S	EUDAMEDFDA UDI	Class I	Active
MR-SPOT Packets	184	EUDAMEDFDA UDI	Class I	Active
MR-SPOT Packets	185S	EUDAMEDFDA UDI	Class I	Active
S-Spot	777	EUDAMEDFDA UDI	Class I	Active
TomoSPOT	781S	EUDAMEDFDA UDI	Class I	Active
InkRight	512	EUDAMED	Class I	Active
D-Spot	104	EUDAMEDFDA UDI	Class I	Active
Rt-Spot	135S	EUDAMEDFDA UDI	Class I	Active
V-Spot	603	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (10)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jun 13, 2018	Z-2832-2018	—	terminated	There is a potential for imaging artifact to mimic calcifications on patient's mammograms
Jun 13, 2018	Z-2831-2018	—	terminated	There is a potential for imaging artifact to mimic calcifications on patient's mammograms
Jun 13, 2018	Z-2830-2018	—	terminated	There is a potential for imaging artifact to mimic calcifications on patient's mammograms
May 8, 2017	Z-2309-2017	—	terminated	Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels
Jun 19, 2013	Z-1787-2014	—	terminated	Light Image O-Spots Dispenser mislabeled as Soft n' Stretchy Light Image S-Spots
Jul 9, 2012	Z-2112-2012	—	terminated	Digital Skin Mammography Marker separating from the backing of the spot material
Jul 9, 2012	Z-2109-2012	—	terminated	Digital Skin Mammography Marker separating from the backing of the spot material
Jul 9, 2012	Z-2111-2012	—	terminated	Digital Skin Mammography Marker separating from the backing of the spot material
Jul 9, 2012	Z-2110-2012	—	terminated	Digital Skin Mammography Marker separating from the backing of the spot material
Jul 2, 2012	Z-2080-2012	—	terminated	Imaging artifact can occur on mammogram result